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At least 91 records · Page 5Linked to original sources
PubMed1998

Nomegestrol acetate contraceptive implant use by women with sickle cell disease.

OBJECTIVE: To assess the contraceptive effectiveness, safety, and potential health benefits of nomegestrol acetate contraceptive implant use by women with homozygous sickle cell disease (hemoglobin SS). METHODS: This was a prospective observation before and after insertion of nomegestrol acetate of 20 women with sickle cell disease (test group) compared with 10 women with similar sociodemographic backgrounds. Changes in hematologic and biochemical parameters and symptoms of sickle cell crisis were measured during 12 months of observation. RESULTS: After use of nomegestrol acetate for 1 to 9 months, the women in the test group had symptomatic improvement, with no crisis that required hospitalization and no deaths. Sickle cell symptoms persisted in the women in the control group, with 1 recorded death. Increases in F-cell and fetal hemoglobin parallel the observed clinical improvement in the treated women. There were no adverse hematologic or biochemical changes associated with the use of nomegestrol acetate implants. CONCLUSION: Nomegestrol acetate appears to be a safe and appropriate contraceptive for women with sickle cell disease, showing evidence of being a "stimulant" for F-cell reactivation, independent of F hemoglobin total production increase.

Adult↗
PubMed1997

Changes in the menstrual bleeding of users of a subdermal contraceptive implant of nomegestrol acetate (Uniplant) do not influence sexual frequency, sexual desire, or sexual enjoyment.

OBJECTIVE: To evaluate the effect of menstrual changes induced by a nomegestrol acetate subdermal contraceptive implant (Uniplant; Thermex, Bahia, Brazil) on users' sexuality. DESIGN: Prospective observational survey. SETTING: San Borja-Arriarán Hospital, University of Chile, School of Medicine. PATIENT(S): Normally cycling healthy women and their partners. INTERVENTION(S): Structured interview before and during use of the contraceptive. MAIN OUTCOMES MEASURE(S): Sexual frequency, desire, and enjoyment; perception of health; and contraceptive satisfaction. RESULT(S): During the use of the implant more women reported irregular cycles (32% versus 11%) and vaginal spotting (38% versus 19%). Frequency of sexual relations was unchanged (2.3 versus 2.5/wk) but the percent of couples engaging in sexual relations during vaginal spotting increased (28% versus 11%). There was no significant difference in the percent of men or women who reported an increase, or decrease, in perceived sexual desire, sexual enjoyment, or perception of health during the use of Uniplant. CONCLUSION(S): Despite the alterations in menstrual cyclicity and the occurrence of spotting, the use of a contraceptive subdermal implant of nomegestrol acetate did not effect desire for, enjoyment of, or frequency of sexual relations in users.

Adolescent↗
PubMed1998

Young women's attitudes toward injectable and implantable contraceptives.

STUDY OBJECTIVE: To assess the potential acceptability of implantable and injectable contraceptive characteristics by young women of diverse ethnic and educational backgrounds. DESIGN: A cross-sectional self-administered survey. SETTINGS: The waiting room of three clinical sites: an elite women's college health service, a coeducational state university health service, and an inner city hospital-based adolescent clinic. PARTICIPANTS: 328 young women awaiting medical care in one of three clinical sites, aged 13 to 21 years (85% 18-21 years); ethnic distribution differed significantly by site. The majority (83%) were sexually active, and of those who were sexually experienced, 25% had been pregnant. OUTCOME MEASURES: A 47-item questionnaire examining attitudes toward characteristics of injectable and implantable contraceptive methods, menstrual, sexual, and gynecologic history. RESULTS: Sixty-two percent of the sample agreed that they would get an injectable method. There was little variation in agreement to get an injectable method by sexual or pregnancy history. Fewer subjects (24%) agreed that they would like to get subdermal implants and agreement to get an implantable method of contraception did not vary by sexual history; however, ever-pregnant young women (33%) were significantly more likely to agree to implants than never-pregnant subjects (21%; chi2, 4.109; p = 0.04). Seventy-four percent of subjects said they would stop using a contraceptive that caused irregular menses, whereas 65% would stop using a method that caused amenorrhea. CONCLUSIONS: An injectable contraceptive method has universal appeal across ethnic, educational, and age categories, whereas implants are less appealing. Irregular bleeding and amenorrhea are poorly perceived side effects of long-acting contraceptives.

Adolescent↗
PubMed1992

Injectable and implantable contraceptives.

In December 1990, the Food and Drug Administration approved Norplant (Wyeth-Ayerst, Radnor, PA) for general US use. This approval comes during a time period when the number of contraceptors relying on sterilization has risen, echoing known dissatisfaction with other reversible methods. During the past year, data have been presented that refute concern that Norplant may be an abortifacient. Continued estradiol production with development of follicles and ovulation in regularly menstruating women was documented. Ovulatory dysfunction among Norplant users, despite follicular development, was also detailed. Changes in carbohydrate metabolism were confirmed to be clinically insignificant. International development of biodegradable and non-biodegradable implants and 1, 3, or 6 months injectables continues. These injectable and implantable contraceptives promise diversity in contraceptive options to match diversity in contraceptive need and life style.

Capsules↗
PubMed1998

Depressive symptoms and Norplant contraceptive implants.

Women enrolled in a multicenter prospective study were evaluated to identify any possible relationship between depressive symptoms and the use of contraceptive implants. Women choosing Norplant implants (n = 910) were evaluated before starting this contraceptive and were reinterviewed at 6 months and 2 years. Women who continued the method had lower depressive symptom scores before initiating Norplant implants than did the women who discontinued the method or who were lost to follow up. Among the continuing Norplant implant users, the mean scores were similar before starting Norplant and at 6 months (7.9 vs 7.7). The strongest overall predictor of the depressive symptom score was relationship satisfaction. At 24 months, the subgroup of continuing users with decreased relationship satisfaction had an increase in depressive symptom score, but those with stable or improved relationships had stable depressive symptom scores. The subjects with the highest (i.e., worst) scores at enrollment demonstrated improved scores during follow-up. These results are reassuring for women who are concerned that Norplant use may adversely affect their mood.

Adolescent↗
PubMed2004

[Acceptability of the etonogestrel-containing contraceptive implant (Implanon)].

OBJECTIVES: To estimate the exact satisfaction of women toward Implanon, the sole contraceptive implant available in France. To clarify the indications of this type of contraception. MATERIAL AND METHOD: Among a population of 182 women with Implanon" inserted in a same family planning service between May 22, 2001 and February 14, 2003, 108 women agreed to answer a questionnaire of satisfaction. Implants were inserted in one third of cases after childbirth, in another third after abortion. The average duration of use of the implant was of 16 months (2 in 24 months). Twenty-nine removals among the 108 insertions (27%) were recorded. RESULTS: Possibility of a long-term and easy -to-use contraception was the most common reason for choosing Implanon (74% of the women). Eighty-one percent of the women were globally satisfied with Implanon but one out of two women had side-effects. Only 62% of the women were ready to use it again. Adverse events were first, menstrual disturbance in 83% of the women, mainly amenorrhea (26%) and bleeding irregularity (40%). Bleeding irregularity was one of the main motives for discontinuing the implant in 41% of cases. Except weight gain present for 37% of patients, the other side-effects, even though they were frequent, were less often the reason for removal. Headache, acne, breast pain, mood and decreased libido were the main reasons for removal. CONCLUSION: Implanon has certainly a place among current contraceptive methods. Because of the frequency raised by adverse events and by their lower tolerance in Europe, this place has to remain limited to the incapacity of classic methods. Preinsertion counseling announcing Implanon's benefit and risk effects is necessary to minimize the early discontinuation rates.

Adolescent↗
PubMed2000

Prevalence of enlarged ovarian follicles among users of levonorgestrel subdermal contraceptive implants (Norplant).

OBJECTIVE: The aim of this study was to determine the prevalence of enlarged follicles, as detected by a single clinical or ultrasonographic examination, among users of levonorgestrel subdermal contraceptive implants (Norplant implants). STUDY DESIGN: This was a cross-sectional study of 103 users of Norplant implants and 50 users of the TCu380A intrauterine contraceptive device, all of whom received reproductive health services from PROFAMILIA, Santo Domingo, Dominican Republic. Bimanual pelvic examination and vaginal ultrasonography were performed. Enlarged follicles (>25 mm) were followed up weekly. The chi(2) test was applied to these data. RESULTS: Enlarged follicles were detected by ultrasonography in 17. 5% of Norplant implants users and 4% of TCu380A intrauterine contraceptive device users, respectively (P <.04). There was no difference according to duration of use. The longest time to involution of the follicles was 4 weeks. Forty percent of the enlarged follicles detected by ultrasonography were also detected by bimanual pelvic examination. CONCLUSION: Enlarged follicles are a frequent finding among women who use Norplant implants, but they are less frequent than described in previous studies, which were based on serial ultrasonographic scans in selected groups of users. Physicians and users should be aware of the transient nature of these enlarged follicles, which do not require intervention.

Contraceptive Agents, Female↗
PubMed1996

Patient satisfaction with a levonorgestrel-releasing contraceptive implant. Reasons for and patterns of removal.

OBJECTIVE: To investigate the experience of the users of a levonorgestrel-releasing contraceptive implant (Nor-plant) and reasons for early removal. STUDY DESIGN: Two hundred fifty-one women who had Norplant placed through the Ohio State University Department of Obstetrics and Gynecology were sent a questionnaire that included general demographic questions and questions regarding preplacement education; reasons for choosing Norplant; problems experienced due to Norplant; reasons for removal, if applicable; and overall satisfaction. RESULTS: One hundred eleven questionnaires (44%) were completed and analyzed. Twenty-four (21.6%) of patients had Norplant removed, 32 (28.8%) planned on early removal, and 55 (49.5%) desired continued use. Ninety-eight percent of women who planned continued use of Norplant had received reading material as part of their preplacement counseling and 95% felt adequately counseled. This is significantly higher than women who had Norplant removed or planned on early removal. Convenience, problems with other contraceptive methods and effectiveness were the most important reasons why patients chose Norplant. Menstrual changes were the most common side effect, experienced by 80% of all women in the study. Weight gain, headache, mood changes, mastalgia and acne were also frequently reported. Women who had Norplant removed were significantly more likely to have experienced dizziness when compared to women desiring continued use. Women planning early removal were also more likely to have experienced dizziness in addition to acne, headache, hair loss and other side effects. Menstrual irregularities, followed by mood changes and headaches, were the most important side effects associated with early Norplant removal. Overall, 68% of users were at least somewhat satisfied with Norplant. CONCLUSION: Norplant contraception was a satisfactory form of birth control for the majority of patients in the study despite the frequent occurrence of side effects. Reading material regarding benefits and side effects of Norplant is an important aspect of patient counseling and may improve long-term use of Norplant.

Adolescent↗
PubMed2005

Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel.

OBJECTIVES: The safety and efficacy of a single-rod implantable contraceptive containing etonogestrel (Implanontrade mark) were investigated in a multicenter clinical trial. STUDY DESIGN: Sexually active American women (N=330) with apparently normal menstrual cycles used the implant for up to 2 years. All subjects recorded bleeding and/or spotting daily in a diary. Safety was assessed through adverse experiences (AEs), laboratory tests and physical and gynecologic examinations. RESULTS: Total exposure was 474 woman-years (6186 cycles), and 68% of subjects had at least 1 year of exposure. No pregnancies occurred. The most common bleeding pattern observed throughout the study was infrequent bleeding, defined as less than three episodes of bleeding in a reference period (excluding amenorrhea). The least common pattern was frequent bleeding, defined as more than five episodes of bleeding in a reference period. Infrequent, prolonged and frequent bleeding patterns were most common early in the study and declined thereafter. During the 3-month Reference Periods 2-8 (Months 4-24), the incidence of amenorrhea ranged from 14% to 20%. Forty-three subjects (13%) withdrew from the study because of bleeding pattern changes and 76 subjects (23%) discontinued because of other AEs. Other common AEs leading to discontinuation, besides bleeding irregularities, were emotional lability (6.1%), weight increase (3.3%), depression (2.4%) and acne (1.5%). Use of Implanon (etonogestrel subdermal implant, referred to herein as ENG implant) for up to 2 years had no clinically significant effects on laboratory parameters, physical and pelvic examinations, vital signs or body mass index. The average length of time required for ENG implant insertion and that for removal were 0.5 and 3.5 min, respectively, and all the procedures were uncomplicated. The return to normal menstrual cycles and fertility was rapid after removal. CONCLUSIONS: Implanon is a safe, highly effective and rapidly reversible new method of contraception.

Acne Vulgaris↗
PubMedDate not supplied

Public funding and policies for provision of the contraceptive implant, fiscal year 1992.

According to results of a survey of state Medicaid, health and welfare agencies, these agencies spent $61 million in federal and state funds on the provision of the contraceptive implant to low-income women in FY 1992. Some $57 million of this was federal funds, with Medicaid accounting for 84% of all public funds spent on the implant; only nine states committed monies from their own coffers. The Medicaid agencies of 13 states reported restrictions on the number of subsidized implants a woman could receive over her reproductive lifetime. No Medicaid agency has provisions to cover required or requested removals of the device among users who become ineligible for Medicaid while the implant is in place; only eight health departments have policies ensuring subsidized removals for such women.

Contraceptive Agents, Female↗
PubMed2001

Implant contraception.

The experience of 6 million Norplant users has led to several more advanced implants. Implanon is a single-rod implant system containing a low androgenic progestin and requires 1 to 2 minutes for insertion and removal. Like other implants, Implanon prevents pregnancy by changing the character of the cervical mucus and interfering with luteal function. Unlike Norplant, though, Implanon is designed to prevent ovulation for the full duration of use. Implant contraception has several advantages over other types of contraception including high efficacy, minimal required maintenance, absence of estrogen, and rapid return of fertility after discontinuation. Implants can be a good choice for adolescents; women with hypertension, diabetes, anemia, endometriosis, or other medical problems; and women who are breast-feeding. Irregular bleeding is the most common adverse effect of implants and can be treated with several medication regimens. Preinsertion counseling, however, is the most important factor in ensuring satisfaction with implants. Unfortunately, no implant system is currently available in the United States since August 2000, but Implanon is expected to reach the U.S. market within the next 2 years.

Cervix Mucus↗
PubMed1998

A 2-year comparative study of endometrial histology and cervical cytology of contraceptive implant users in Birmingham, UK.

The objectives of this study were to evaluate the endometrial histology and cervical cytology of users of two contraceptive implants releasing etonogestrel/3-keto-desogestrel (Implanon) and levonorgestrel (Norplant) in West Midlands (UK) users. A 2-year prospective randomized design was used to study 60 implant users. Endometrial histology and cervical cytology were compared before insertion and after 12 and 24 months. At the end of 12 months, the majority of samples were inactive/weakly proliferative in both groups. At the end of 24 months, this remained unchanged in the Implanon group whereas the pattern was more diverse in the Norplant group. Endometrial thickness was significantly reduced in both groups during treatment. Cervical cytology remained unchanged. It is concluded that, after 2 years, there was no evidence of an increasing risk of endometrial hyperplasia, endometrial carcinoma, cervical intra-epithelial neoplasia or cervical carcinoma in either of the two groups of implant users.

Adolescent↗
PubMed1996

Multicenter clinical trial on the efficacy and acceptability of a single contraceptive implant of nomegestrol acetate, Uniplant.

Uniplant, a single Silastic implant containing nomegestrol acetate, provides contraceptive efficacy for one year. Uniplant use for one year was studied in 1,803 healthy women of reproductive age, enrolled from 10 centers in 9 countries, after informed consent. Implants were placed subdermally either in the upper arm or in the gluteal region. Two-hundred-seventy-six subjects discontinued prior to completing one year of study. Cumulative discontinuation rate at 12 months was 15.72%. Medical reasons for discontinuation were principally menstrual-related. Fifteen pregnancies occurred during the one year study period, resulting in a 12-month net cumulative pregnancy rate of 0.94%. Approximately 56% of subjects using Uniplant had bleeding patterns similar to normal menstruation. Results from this study confirm that Uniplant is an efficient, well tolerated, 12-month contraceptive implant, with the advantage of easier insertion and removal of the single implant compared to other multiple implant methods.

Adult↗
PubMed1999

GyneFIX. The frameless intrauterine contraceptive implant--an update for interval, emergency and postabortal contraception.

This article reviews the clinical experience with the GyneFix intrauterine implant system for interval, emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women. The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnacies and induced abortions.

Abortion, Induced↗
PubMed1995

Insulin sensitivity is unaltered by the use of the Norplant subdermal implant contraceptive.

Prior evaluations of carbohydrate metabolism in Norplant implant users, using the oral glucose tolerance test, have shown mild but clinically insignificant deterioration of insulin sensitivity. Using the more sensitive insulin tolerance test, the effects of the Norplant implant system on insulin sensitivity was studied in normal women. Insulin tolerance tests were performed before Norplant implant insertion in ten ovulatory female volunteers and repeated after 12 weeks of use. Both fasting glucose and fasting insulin values were similar before and after the use of Norplant implants. There was no significant difference in either the Kitt glucose value or the Kitt insulin value at baseline and at 3 months of use. Furthermore, the insulin-to-glucose ratio did not differ before and after the use of Norplant implants. There was a significant correlation with BMI and Kitt glucose value (r = -0.45, p < .05), as well as between fasting insulin and BMI (r = 0.6, p = 0.006). In the first three months of use, the levonorgestrel-containing implant system, Norplant, does not affect sensitivity to insulin or glucose in normal, nondiabetic women.

Administration, Cutaneous↗
PubMed2002

Surface vascularization and endometrial appearance in women with menorrhagia or using levonorgestrel contraceptive implants. Implications for the mechanisms of breakthrough bleeding.

BACKGROUND: Women using progestogen-only contraceptives are commonly troubled by irregular bleeding. Endometrial vessel breakdown and repair is thought to be locally regulated under the indirect influence of sex steroids. Most information about endometrial vessels is derived from blind biopsies taken in an outpatient setting. Hysteroscopy allows in-vivo observation of the whole endometrial surface, including vessel morphology, distribution and areas of bleeding, as well as information about non-vascular structures that may not be accessible from biopsies. METHODS: Hysteroscopies were performed on 34 women using the levonorgestrel contraceptive implant system (Norplant(TM)) and in a comparison group of 20 women complaining of menorrhagia due to ovulatory dysfunctional bleeding. The images were captured and vascular appearances assessed using image analysis. RESULTS: The percentage of the superficial endometrium covered with blood vessels was found to be significantly greater in Norplant users compared with the comparison group (P = 0.0006). More superficial vessels were seen in those with recent frequent or prolonged bleeding and spotting (P < 0.0001). In Norplant users, but not in the comparison group, superficial vascular distribution was predominantly patchy (P < 0.0001). Unusual vascular appearances classified as 'neovascular' (P < 0.0001) and 'mosaic' (P < 0.0001) patterns were commonly seen in Norplant users but not in the comparison group. The hysteroscopic appearance of the endometrial epithelium, glands and stroma also differed between Norplant users and women with menorrhagia. Apparent shedding of the superficial endometrium was commonly seen by hysteroscopy in Norplant users during a bleeding episode (P < 0.0001). Prominent gland openings with thick mucus were commonly seen in Norplant users and small sessile polyps were seen in six cases. CONCLUSIONS: These hysteroscopic observations provide further evidence that exposure to progestogens alters the superficial endometrial vasculature and may interfere with angiogenesis.

Adult↗