Immediate postpartum insertion of the Norplant* contraceptive devicet:t:

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1 FERTILITY AND STERILJTY Copyright" 1996 Amerian Soiety for Reprodutive Mediine Printed on aid-free paper in U. S. A. Immediate postpartum insertion of the Norplant* ontraeptive deviet:t: John R. Molland, M.D. David B. Morehead, D.O. David M. Baldwin, Ph.D. V. Daniel Castraane, Ph.D.11 Bill Lasley, Ph.D. ~ Carol A. Bergquist, M.D. ** Texas Teh University Health Sienes Center at Odessa and Amarillo, Texas and University of California at Davis, Davis, California Objetive: To determine the safety and effiay of Norplant (Wyeth-Ayerst Laboratories, Philadelphia, PA) insertion immediately postpartum. Design: Prospetive study of 14 women reeiving Norplant immediately postpartum ompared with ontrols (n = 6) having a bilateral tubal ligation. Subjets were followed for 3 months postpartum, and data were analyzed by analysis of variane and X 2 Setting: Aademi Health Sienes Center. Patients: Female subjets 18 to 35 years old who had an unompliated term pregnany, normal spontaneous vaginal delivery, and did not breast-feed. Intervention: A briefinterview, physial exam, and blood and urine samples were evaluated during a 12-week postpartum period. Main Outome Measures: Major omplaints, serum hemistry panels, hematologi and oagulative measures, serum E 2, P, levonorgestrel, PRL, LH, FSH, and urinary estrone-3 onjugates and pregnanediol-3-gluuronide onentrations. Results: Serum levonorgestrel peaked at approximately 2,000 pg/ml (6,400 pmolll) during the 1st week after Norplant insertion, delining to approximately 250 pg/ml (800 pmolll) by the 8th week. Signifiant differenes between Norplant and ontrol groups inluded bleeding irregularities, headahes, alopeia, and abdominal disomfort. Serum eletrolytes, metaboli markers, and blood omponents were within normal limits. Serum E2, P, and urinary steroid biomarkers indiated that steroid seretion was suppressed severely in the Norplant group ompared with ontrols who exhibited normal postpartum ovarian ativity. Conlusion: Norplant inserted immediately postpartum appears to be a safe and effetive method of ontraeption. However, the long-term hypoestrogeni state and ontraeptive effiay beyond the 3-month postpartum period as observed in this study are onerns that need further linial evaluation. Fertil Steril 1996;66:43-8 Key Words: Norplant, immediate postpartum, blood hemistries, hematologi and oagulation effets, E 2, P, urinary steroid metabolites, PRL, levonorgestrel Norplant (Wyeth-Ayerst Laboratories, Philadelphia, PA) is a long-lasting reversible ontraeptive method onsisting of subdermal implants of Silasti Reeived Otober 2, 1995; revised and aepted February 6, * Norplant, Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania. t Presented at the 50th Annual Meeting of The Amerian Soiety of Reprodutive Mediine, San Antonio, Texas, November 5 to 10,1994. :j: Supported in part by a Faulty Researh Grant, Texas Teh University Health Sienes Center, Lubbok, Texas. Department of Obstetris and Gyneology, Texas Teh University Health Sienes Center at Odessa. apsules (Dow Corning, Midland, MI) ontaining levonorgestrel, whih provides effetive hormonal ontraeption for up to 5 years. It has a lower failure rate than oral ontraeptives, most intrauterine devies, and is omparable to surgial sterilization in its first 3 years of use (1-7). Providing a wide variety of ontraeptive options II Department of Obstetris and Gyneology, Texas Teh University Health Sienes Center at Amarillo. ~ Division of Reprodutive Biology and Mediine, Department of Obstetris and Gyneology, University of California at Davis. ** Reprint requests: Carol A. Bergquist, M.D., Department of Obstetris and Gyneology, Texas Teh University Health Sienes Center, Odessa, Texas (FAX: ). MoHand et ai. Postpartum insertion of Norplant devie 43

2 F is essential in addressing the urrent problems of high rates of unintended pregnanies, the teenage pregnany risis, as well as the relatively high failure rates and ompliane diffiulties assoiated with the typial use of reversible methods of ontraeption. The safety and effiay of Norplant has been established when inserted during the first 7 days of the menstrual yle or immediately after abortion or misarriage (2). It has been reommended that insertion be done no earlier than 6 weeks postpartum (7). At the time the present study was undertaken, there was little information regarding Norplant insertion in the immediate postpartum period. Beause a signifiant segment of our patient population in southwest Texas is relatively transient and impoverished, it was believed to be important to offer a ontraeptive proedure that was long lasting and reversible, funded when performed immediately postpartum, well tolerated, and an effetive method of preventing unplanned pregnanies beginning during the immediate postpartum period. Sine the initiation of our study, a reent report by Phemister et al. (8) indiated that Norplant is well tolerated when inserted immediately postpartum. These onlusions were based mainly on history and physial exam data olleted at the 4 to 6 week postpartum period. The results of the present study onfirm these findings and further extend the observations to hanges in blood hemistries, oagulation onsiderations, omplete blood ounts, and evaluation of seleted hormonal parameters of pituitary and ovarian funtion. Study Subjets MATERIALS AND METHODS Study subjets inluded a female patient population 18 to 35 years old who reeived their initial prenatal are before 25 weeks, had an unompliated term pregnany, normal vaginal delivery, and did not breast feed. Exlusionary riteria inluded women who had medial ompliations suh as diabetes, hypertensive disorders of pregnany, postpartum hemorrhage, or infetion, or a history of substane abuse. The patient population was mostly indigent, onsisting of Hispani and non-hispani whites who reeived are at one of the Department of Obstetris and Gyneology's ommunity linis. The study was approved by the Institutional Review Boards for The Protetion of Human Subjets by Texas Teh University Health Sienes Center, Lubbok, Texas and the Medial Center Hospital, Odessa, Texas. Study Design This was a prospetive study onsisting of two groups of women, an experimental group reeiving 44 Molland et al. Postpartum insertion of Norplant devie the Norplant Devie (six flexible silasti apsules eah ontaining 36 mg of levonorgestrel) and a ontrol group of women who had undergone a bilateral tubal ligation immediately postpartum. The study was onduted from Deember 1992 to Otober Norplant insertion or tubal ligation was performed within 48 hours of delivery and the subjets were followed for 3 months postpartum. A total of 15 Norplant subjets and 8 ontrol subjets were reruited, of whih 11 Norplant and 6 ontrol subjets ompleted the full 3-month study. Data olleted from three Norplant and one ontrol subjets who ompleted a total of four to five onseutive visits (Le., 1 or 2 months) before withdrawing from the study were inluded in the analyses. Periodi assessments of the patient were made at 0, 1, 2, 3, 4, 8, and 12 weeks after delivery. At eah time period, the patient was interviewed regarding symptoms and side effets, a brief physial examination was performed (inluding body weight, blood pressure, abdominal palpation of the uterus, and evaluation of any other onerns), and blood samples were taken for laboratory monitoring of omplete blood ounts, serum hemistry analyses, prothrombin and partial thromboplastin times, and serum hormone onentrations. Ovarian ativity was monitored by determining daily urinary onentrations (first morning void) of estrogen-onjugated metabolites, estrone-3-gluuronide and estrone-3-sulfate (EIC; as a measure of folliular ativity) and the major P-onjugated metabolite, pregnanediol-3-gluuronide (PDG; as a measure of luteal funtion) (9, 10), as well as serum measurements of E2 and P at weekly or monthly intervals. Assays Blood hemistries were measured by the biohemistry laboratory at the Medial Center Hospital, Odessa, Texas. These inluded serum onentrations of sodium, potassium, hloride, arbon dioxide, gluose, blood urea nitrogen, reatinine, uri aid, alium, phosphorous, total bilirubin, total protein, albumin, triglyerides, and holesterol, enzyme ativities of aspartate aminotransferase, serum alanine aminotransferase, alanine transferase, latate dehydrogenase, and alkaline phosphatase, and hematologi and oagulation tests, inluding white blood ell and platelet ounts, hematorit, hemoglobin, prothrombin time, and partial thromboplastin time. Serum hormone onentration of PRL, LH, and FSH was measured by ommerial RIA kits (Diagnosti Produts Corporation, Los Angeles, CA). Interassay oeffiients of variation (CV) were 9.34% for LH, 4.87% for FSH, and 9.30% for PRL. Intra- Fertility and Sterility

3 ::; 1.8 E a. 1.6.s- 1.4 ~ ~ ".. > J E 0.6 en ~ BASAL WKl WK2 WK3 WK4 WK8 WK12 Time after Norplant Insertion (wks) Figure 1 Serum levonorgestrel onentrations in patients just before (basal) and at different times after Norplant insertion. The bars represent the mean and the vertial line represents the SEM (n = 12). assay CVs were all <5.0%. Estradiol and P were measured by a hemiluminesene automated assay immulite (Diagnosti Produts Corporation) with interassay CVs of <12.4% and intra-assay CVs of <5.0%. Urinary E1C and PDG were measured by enzyme immunoassays (EIA) as desribed and validated previously by Munro et al. (9). Steroid metabolite onentrations were estimated by absorbane values (as determined on a mirotiter plate reader, Dynateh 5000, Chantilly, VA) using a four-parameter linear regression logisti transformation proedure (11). The urinary steroid onjugates were normalized to urinary reatinine onentrations as determined olorimetrially by the method of Taussky (12). Intraassay and interassay CVs were 6.3% and 12.8% for E1C and 5.3% and 7.9% for PDG. Serum levonorgestrel onentrations were measured by an EIA as desribed reently by Munro et al. (Munro CJ, Laughlin LS, Von Shalsha TL, Lasley BL, abstrat). Intra-assay and interassay CVs were 3.9% and 5.9%, respetively. Data Analysis Data were analyzed statistially by X 2 analysis-ofontingeny tables or Fisher's exat test for nominal values and by two-way analysis of variane for ontinuous data. Differenes between means with a P < 0.05 were onsidered statistially signifiant. RESULTS As illustrated in Figure 1, serum levonorgestrel levels were elevated to approximately 2,000 pg/ml (6,400 pmolll) the 1st week after insertion of the implants and delined preipitously until approxi- mately the 8th week to a steady level of approximately 250 pg/ml (800 pmolll). No major side effets or problems of the immediate postpartum insertion were observed. The most ommon symptoms of a total of 21 different symptoms evaluated inluded bleeding irregularities, pain at the insertion site, headahes, hanges in weight, mastalgia, alopeia, abdominal disomfort, and depression. Of these, the symptoms that were desribed more frequently in the Norplant group were irregular bleeding (P < 0.01), headahes (P < 0.01), alopeia (P < 0.05), and abdominal disomfort (P < 0.05). Serum eletrolyte onentrations measured during the 3-month postpartum period in the Norplant and ontrol groups were within the normal range and were not hanged with duration oftime postpartum. However, serum sodium, alium, and hloride onentrations were elevated signifiantly (P < 0.01) in the Norplant group ompared with ontrols. Various serum metaboli biomarkers assessed (inluding holesterol, triglyerides, gluose, total protein, albumin, blood urea nitrogen, bilirubin, uri aid, and reatinine) also were in the normal range in both treatment groups, with holesterol dereasing and total protein and albumin inreasing with time postpartum (P < 0.01). Cholesterol (P < 0.05) and triglyerides (P < 0.01) were lower (7.5% and 40.5%, respetively) and bilirubin (P < 0.01) was higher (31.4%) in women reeiving the Norplant devie as ompared with ontrols. Ativities of various enzyme markers inluding aspartate aminotransferase, alanine serum transferase, lati dehydrogenase, and alkaline phosphatase were in the normal range in both the Norplant and ontrol groups. However, the Norplant resulted in a slight derease in the ativity of alanine serum transferase and alkaline phosphatase (P < 0.05). Moreover, both lati dehydrogenase (LDH) and alkaline phosphatase dereased with time postpartum, independent of treatment (P < 0.01). Evaluation of the effets of the levonorgestrel implants on various hematologi and oagulopathi fators indiated no differenes in the white blood ell ount (WBC), hemoglobin, hematorit, platelet ount, prothrombin time, and partial thromboplastin time between the Norplant and ontrol groups. However, women inserted with the Norplant devie had signifiantly (P < 0.01) lower onentrations of WBCs (20%), hemoglobin (7.8%), and hematorits (4.5%) and a slightly elevated partial thromboplastin time (5.0%). Serum PRL onentrations were similar in both treatment groups, being elevated during the early postpartum period and delining to low levels «10 ng/ml) by week 12. This study was not designed to evaluate the pulsatile nature oflh and FSH release, MoHand et a1. Postpartum insertion of Norplant devie 45

4 OJ 200 ~ 0 o E W o a a DAYS POSTPARTUM CD 3 CD :s i: OJ ii CD 30 0 ~ at 2 o E E Cl D- at " a a DAYS POSTPARTUM 40 W o Figure 2 Daily onentrations of the urinary estrogen onjugates, estrone-3-sulfate and estrone-3-gluuronide (ElC), in individual patients over a 3-month period after reeiving insertion of a Norplant. All values are normalized to the orresponding urinary reatinine onentration. Figure 4 A representative sample of daily urinary ElC and PDG at various times after parturition in a ontrol subjet reeiving a bilateral tubal ligation. All values are normalized to the orresponding urinary reatinine onentration. ElC, 0; PDG, e. i.e., blood samples were taken only one weekly or monthly. Therefore, although mean levels were low, a meaningful omparison of gonadotropin onentrations between the Norplant and ontrol groups ould not be made due to the large degree of sample variability (data not shown). Individual patterns of daily urinary EIC and PDG onentrations over the 3-month postinsertion period of the Norplant devie are depited in Figures 2 and 3, respetively. Both EIC and PDG levels dropped preipitously within the first few days postpartum and remained low with random variability without any apparent yli pattern of exretion. Serum levels of E2 and P taken at weeks 1,2, 3,4, 8, and 12 also were found to be low, with a mean level of ± 1.07 pg/ml (83.6 pmol/l) for E2 and OJ CD 0 6 CD E 5 -Cl 4 D- at 3 " 2 o DAYS POSTPARTUM Figure 3 Daily individual urinary onjugated P metabolite, pregnanediol gluuronide (PDG), onentrations at various times in women who have reeived a Norplant. All values are normalized to the orresponding urinary reatinine onentration. ± 0.02 ng/ml (0.95 nmol/l) for P. There were no signifiant differenes in serum steroid onentrations with time postpartum. In ontrast, bilateral tubal ligation ontrol subjets exhibited a yli pattern of urinary EIC and PDG onentrations. The EIC and PDG patterns illustrated in Figure 4 are typial examples, showing apparent ovulatory yles in a bilateral tubal ligation ontrol subjet beginning approximately day 20 postpartum followed by two additional yles throughout the remainder of the 12-week period. Other ontrol subjets were more variable, with one to two apparent yles with lear indiations offolliular (i.e., elevated EIC levels) or luteal phase (i.e., elevated PDG levels) ativity. DISCUSSION The Norplant ontraeptive devie approved in the United States in 1991 onsists of subdermal implants of Silasti apsules ontaining levonorgestrel, a syntheti progestin (7). Although Norplant has been used by >500,000 women in 45 ountries (13), surprisingly little information has been published on insertion of the N orplant devie immediately postpartum. The objetive ofthis study was to evaluate further the safety and effiay of the Norplant system when inserted in the immediate postpartum period. A reent report by Phemister et al. (8) that appeared while this study was in progress onluded that Norplant is well tolerated in the immediate postpartum period. This onlusion was based upon the observations that there was no signifiant effet on blood pressure or hemoglobin in women reeiving the Norplant within 48 hours after delivery ompared with a ontrol group that did not reeive the Norplant until 4 to 6 weeks postpartum. Phemister 46 MoHand et al. Postpartum insertion of Norplant devie Fertility and Sterility

5 et al. (8) also reported that there were signifiantly more bleeding days, frequeny of headahes, and ane ompared with ontrols. Observations from the present study agree with these results in that we also found a signifiantly inreased frequeny of bleeding irregularities (P < 0.01) and omplaints of headahes (P < 0.01) in Norplant users versus the bilateral tubal ligation ontrols. In addition, other symptoms noted more frequently in the present study in the Norplant group inluded alopeia (P < 0.05) and abdominal disomfort (P < 0.05). We found no signifiant effets of the immediate postpartum insertion of the N orplant devie on normal blood eletrolyte onentrations; hanges in lipids, arbohydrates, and other metaboli markers; hepati enzyme markers; or various hematologi and oagulopathi fators. There were signifiant effets of Norplant on various serum hemistry levels ompared with the bilateral tubal ligation ontrols, although all were within the range of normallaboratory values. Furthermore, independent of the treatment group, there were normal postpartum hanges in total holesterol, total protein, and albumin, and the ativity of alkaline phosphatase was onsistent with the hanges that our normally after pregnany (14). Although LDH normally does not hange throughout pregnany (14), there was a signifiant derease during the 3-month postpartum period. Based on these data, it would appear that insertion of the N orplant devie during the immediate postpartum period is safe with no additional side effets of Norplant other than those observed previously in the normal menstruating woman (1-7). As far as the authors are aware, this is the first study in whih serum levonorgestrel onentrations and pituitary and ovarian hormone ativity has been evaluated after N orplant insertion during the immediate postpartum period. The measurement of levonorgestrel in this study showed a rapid release during the first week of implantation to approximately 2,000 pg/ml followed by a preipitous deline during the next 2 months to reah levels of approximately 250 pg/ml. These levels are in ontrast for average release rates reported in normal menstruating women in whih levonorgestrel levels have been shown to inrease up to 500 pg/ml during the first 24 hours and remain relatively onstant during the first year at 400 pg/ml delining to approximately 300 pg/ml up to 3 years (15). Others have reported average levonorgestrel values of approximately 340 to 420 pg/ml (16). Interestingly, Brahe et al. (16) were able to divide their patient population into an ovulatory and anovulatory group based on levonorgestrellevels. In other words, women with mean onentrations of levonorgestrel of 340 ::!:: 111 pg/ml (mean::!:: SD) had a high inidene of ovulatory yles, whereas those with mean onentrations of 420 ::!:: 140 pg/ml were anovulatory. Based on our data, women reeiving the Norplant had little or no ovarian ativity as related to steroid prodution during the entire 3-month postpartum period. Daily urinary E1C and PDG onentrations, whih aurately reflet serum levels of E2 and P, respetively (9, 10), remained suppressed throughout this 3-month period, indiating a lak of folliular development and subsequent ovulation. In ontrast, ontrol women demonstrated yli flutuations in both urinary onjugates beginning as early as 25 to 30 days postpartum with as many as three ovulatory yles during the 12-week study period. The results of our ontrol population are very similar to those desribed previously for normal nonbreastfeeding postpartum women (10). In addition to the urinary steroid onjugate onentrations, serum E2 and P levels also were suppressed severely throughout the 3-month postpartum period in the Norplant group, further indiating a lak of ovarian ativity in this group. As a matter of fat, the Norplant group had mean levels of E2 of 23 pg/ml, whih is similar to onentrations observed in the postmenopausal woman (17). Thus, it would appear that, at least for the duration of the present study, the women reeiving Norplant were hypoestrogeni. Moreover, the low serum P onentrations (0.30 ng/ml) in this same group of women indiate omplete lak of ovulation. Unfortunately, these women were not followed for longer periods of time to determine whether there is a resumption of ovarian ativity. It has been reported that women with regular menstrual yles that have reeived a Norplant have highly variable levels of E2 reahing as high as the preovulatory E2 surge and therefore are never in a prolonged hypoestrogeni state (18, 19). Whether the women in our study would show a resumption of folliular ativity similar to that reported in normal yli women using Norplant (2) remains to be determined. It is ritial that these findings should be evaluated further as a prolonged hypoestrogeni ondition ould have detrimental effets with regard to bone loss and hanges in lipid and arbohydrate metabolism (20). The long-ating syntheti progestin, medroxyprogesterone aetate, has been reported to suppress E2 levels, resulting in a redution of bone density (21). Clearly, prospetive studies onerning this issue are warranted. In the urrent study, we hose to exlude women who wanted to nurse their infant. Levonorgestrel onentrations have been found in maternal milk in variable onentrations, ranging from 23 to 311 pg/ ml (22). It has been estimated that the dose oflevonorgestrel reeived by the infant during the first month of Norplant insertion is approximately 15 to MoHand et al. Postpartum insertion of Norplant devie 47

6 18 ng/kg per day (22). Although progestogen-only ontraeptives (inluding Norplant) used during latation do not appear to alter infant growth and development (23, 24) or milk prodution (25), additional studies on this issue are needed. As seen in the present study, PRL levels that were elevated initially and delined with time postpartum were similar in the ontrol and N orplant groups, suggesting that Norplant did not interfere with the seretion of the latogeni hormone in the nonlatating woman. In onlusion, our data suggest that Norplant is generally a safe and effetive form of ontraeption in the immediate postpartum period. However, two major onerns arise from the findings in these studies. One pertains to the fat that the levels of levonorgestrel delined to approximately 250 pg/ml by 8 to 12 weeks after Norplant insertion in the immediate postpartum period. These levels are similar to those reported for the reommended time for N orplant ontraeptive effetiveness, i.e., approximately 5 years (1-7) and are just slightly higher than onentrations assoiated with pregnany. A seond onern that should be evaluated further when Norplant is implanted during the immediate postpartum period is whether the sustained presene of a syntheti progestogen results in a prolonged hypoestrogeni state. Thus, our results suggest that the long-term safety and effiay of Norplant inserted immediately postpartum needs to be evaluated further. Nonetheless, the progestogen-only ontraeptives are gaining popularity throughout the world as they provide users with a safe, onvenient, highly effetive, long-lasting, and reversible form of birth ontrol. This form of ontraeption is suited espeially for patient populations in whom unwanted pregnanies are ommon, ompliane is low, and follow-up is unertain. REFERENCES 1. Shoupe D, Mishell DR. Norplant: subdermal implant system for long-term ontraeption. Am J Obstet Gyneol 1989; 160: Fats about an implantable ontraeptive: memorandum from a WHO meeting. Bull World Health Organ 1985;63: Darney PD. Hormonal implants: ontraeption for a new entury. Am J Obstet Gyneol 1994; 170: Sivin I. International Experiene with NORPLANT and NORPLANT-2 ontraeptives. Stud Fam Plann 1988;19: Burkman RT. Modern trends in ontraeption. Obstet Gyneol Clin North Am 1990;17: Darney PD, Klaisle CM, Tanner S, Alvarado AM. Sustainedreleased ontraeptives. Curr Prob Obstet Gyneol Fertil 1990; 13: Flattum-Riemers J. Norplant: a new ontraeptive. Am Fam Physiian 1991;44: Phemister DA, Laurent S, Harrison FNH Jr. Use ofnorplant ontraeptive implants in the immediate postpartum period: safety and tolerane. Am J Obstet GyneoI1995;172: Munro CJ, Stabenfeldt GH, Cragun JR, Addiego A, Overstreet JW, Lasley BL. Relationship of serum estradiol and progesterone onentrations to the exretion profiles of their major urinary metabolites as measured by enzyme immunoassay and radioimmunoassay. Clin Chem 1991;37: Gray RH, Campbell OM, Zaur HA, Labbok MH, MaRae SL. Postpartum return of ovarian ativity in nonbreastfeeding women monitored by urinary assays. J Clin Endorinol Metabol 1987;64: Robard D. Statistial quality ontrol and routine data proessing for radioimmunoassays and immunoradiometri assays. Clin Chem 1974;20: Taussky HH. A miroolorimetri determination of reatinine in urine by the Jaffe reation. J BioI Chem 1954;208: Herbst AL, Mishell DR Jr, Stenhever MA, Droegemueller W. Comprehensive gyneology. St Louis: Mosby Year Book, Lind T. Maternal physiology. Washington, DC: Counil on Resident Eduation in Obstetris and Gyneology, Moore DE, Roy S, Stanzyk FZ, Mishell DR. Bleeding and serum d-norgestrel, estradiol and progesterone patterns in women using d-norgestrel subdermal polysiloxane apsules for ontraeption. Contraeption 1978; 17: Brahe V, Faundes A, Johansson E, Alvarez F. Anovulation, inadequate luteal phase and poor sperm penetration in ervial muus during prolonged use of Norplant R implants. Contraeption 1985;31: Kuller LH, Mellahn EN, Gutal J, Cauuley J, Wing RR, Matthews KA, et al. Lipoproteins, estrogens, and the menopause. In: Korenman SG, editor. The menopause. Norwell (MA): Serono Symposia, USA, 1990: Brahe V, Alvarez-Sanhez F, Tejada AS, Cohon L. Ovarian endorine funtion through five years of ontinuous treatment with norplant subdermal ontraeptive implants. Contraeption 1990;41: Faundes A, Brahe V, Tejada AS, Cohon L, Alvarez-Sanhez F. Ovulatory dysfuntion during ontinuous administration of low-dose levonorgestrel by subdermal implants. Fertil Steril 1991;56: Korenman SG, editor. The menopause. Norwell (MA): Serono Symposia, USA, Cundy T, Evans M, Roberts H, Wattie D, Ames R, Reid IR. Bone density in women reeiving depot medroxyprogesterone aetate for ontraeption. Br Med J 1991;303: Diaz S, Herreros C, Juez G, Casado ME, Salvatierra AM, Miranda P, et al. Fertility regulation in nursing women: VII. Influene of NORPLANT R levonorgestrel implants upon latation and infant growth. Contraeption 1985;32: World Health Organization. Progestogen-only ontraeptives during latation: I. infant growth. Contraeption 1994; 50: World Health Organization. Progestogen-only ontraeptives during latation: I. infant development. Contraeption 1994; 50: Cunningham FG, MaDonald PC, Gant NF, Leveno KJ, Lilstrap, editors. Williams Obstetris. Norwalk: Appleton & Lange, Molland et al. Postpartum insertion of Norplant devie Fertility and Sterility

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