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At least 595 records · Page 33Linked to original sources
PubMed1994

Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age.

A comparative study of two low-dose oral contraceptives, gestodene (GES) 75 mcg/ethinyl oestradiol (EE) 30 mcg and desogestrel (DES) 150 mcg/EE 20 mcg, was conducted in women over 30 years of age. This randomised, open-label study was organised in Denmark, Italy, New Zealand and United Kingdom. A total of 505 women received GES/EE and 501 received DES/EE for 6 consecutive menstrual cycles. The two groups were comparable in terms of demographic and gynaecologic characteristics at baseline. However, the menstrual flow length was slightly longer in the GES/EE group before the start of the treatment. The mean age (+/- SD) was 35 +/- 4 years in the GES/EE group and 35 +/- 5 years in the DES/EE group. The subjects in the GES/EE group contributed data for a total of 2800 cycles and those in the DES/EE group, data for 2796 cycles. There were no pregnancies on medication with either preparation. The results showed that there were significantly more normal cycles in the GES/EE group for cycles 1 to 6. Irregular bleeding between withdrawal bleeds occurred in 10% of GES/EE and 18.5% of DES/EE cycles. Absence of all bleeding was reported in 29 (1%) and 63 (2%) cycles, respectively. The incidence of missed pills was low in both groups (11% of cycles). No significant differences were observed in cycle length or withdrawal bleeding episode length. Withdrawal bleeding mean intensity was statistically significantly greater with GES/EE. However, for both preparations, the mean intensity was close to light bleeding. No clinically significant differences were noted in weight, blood pressure, Papanicolaou smears or laboratory data. Sixty-eight (13.5%) subjects in the GES/EE group and 64 (12.8%) in the DES/EE group discontinued before the end of the study. Among them, 37 (7%) and 40 (8%) in the respective groups withdrew because of adverse reactions. There was no difference between groups in terms of primary reasons for withdrawal. The most frequently reported complaints that led to discontinuation in both groups were headache, nausea and metrorrhagia. Breast tenderness led to the discontinuation of 1 subject in the GES/EE group and 3 in the DES/EE group. These results show excellent cycle control, efficacy and very low rate of side effects with both GES/EE and DES/EE. These low-dose oral contraceptives could be well suited to healthy nonsmoking women requiring contraception up to the age of menopause.

Adult↗
PubMed1994

Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial.

A 20 micrograms/24 hours levonorgestrel-releasing intrauterine contraceptive device (LNG-IUD) has, in an open randomized multicenter study, been compared to the copper-releasing device Nova T during 5 years of use; 1821 women had the LNG-IUD and 937 women had the Nova T inserted. The 5-year cumulative gross pregnancy rate was 5.9% for Nova T and 0.5% for the LNG-IUD. The local effect of levonorgestrel in the uterine cavity causes reduction of menstrual blood loss and development of oligo-amenorrhea, and the termination rates because of heavy and/or prolonged menstrual flow were significantly (P < 0.001) lower among LNG-IUD users. However, the gross termination rate because of amenorrhea was 6.0 in this group. Hb increased during use of the LNG-IUD and decreased during Nova T use, and the difference between the devices was statistically significant. The incidence of pelvic inflammatory disease (PID) was low in LNG-IUD users regardless of age, whereas in the Nova T group, the PID rate was increased among the youngest women, which makes the difference between the devices significant (P < 0.01). The gross termination rate for reasons considered to be hormonal was 12.1 in the LNG-IUD group compared to 2.0 in the Nova T group (P < 0.001). The LNG-IUD is a long-acting reversible contraceptive method for 5 years with a pregnancy rate comparable to female sterilization. The incidence of PID is low even in young women. In addition, the positive health effects such as decreased menstrual blood loss and increased blood haemoglobin concentration make the LNG-IUD a favorable combination of hormonal and intrauterine contraception.

Adult↗
PubMed1995

Metabolic parameter, bleeding, and weight changes in U.S. women using progestin only contraceptives.

Our objective was to determine the effect of progestin-only contraceptives on metabolic parameters, bleeding patterns, and weight changes during the first year of use. Seventy-one women (> 95% Caucasian), who were advised regarding contraception alternatives, self-selected levonorgestrel implants (n = 44), depo-medroxyprogesterone acetate (n = 22), or oral norethindrone (n = 5). One year later, 11 levonorgestrel implant and five depomedroxyprogesterone acetate patients were randomly selected to compare (pre- and post-progestin use) levels of cholesterol, triglycerides, low density lipoprotein (LDL), high density lipoprotein (HDL), very low density lipoprotein (VLDL), apolipoproteins A-1 and B-100, bilirubin, and sex hormone binding globulin. Monthly bleeding and spotting records were kept in each group. Body weights were also monitored in each group. No statistically significant differences in metabolic parameters were found between pre- and post-progestin use in the levonorgestrel implant and depo-medroxyprogesterone acetate groups. Continued bleeding patterns were more prominent in the levonorgestrel implant and oral norethindrone groups than in patients receiving depo-medroxyprogesterone acetate. No significant weight gain was detected in any group. No changes in metabolic parameters or weight were noted over the one year of use of levonorgestrel implants or depo-medroxyprogesterone acetate. Depo-medroxyprogesterone acetate had the highest incidence of amenorrhea.

Administration, Oral↗
PubMed1995

A multicentred phase III comparative clinical trial of Mesigyna, Cyclofem and Injectable No. 1 given by intramuscular injection to Chinese women. II. The comparison of bleeding patterns.

Between 1988 and 1992, a randomized phase III clinical trial was conducted in China to compare three monthly injectable contraceptives: Mesigyna, Cyclofem and Injectable No. 1. This paper presents a detailed analysis of the menstrual diaries provided by 5098 (89%) of the subjects. In total, 902, 903 and 913 diaries were analyzed to compare bleeding patterns induced by Mesigyna, Cyclofem and Injectable No. 1. The first withdrawal bleeding usually occurs 14-20 days after the first injection for all three of these preparations. Thereafter, 50% of Mesigyna users had precisely 3 bleeding/spotting episodes every 90 days, 50% of Cyclofem users had 2-3 and 50% of Injectable No. 1 users had 3-4 episodes every 90 days. Relative to users of Mesigyna or Cyclofem, Injectable No. 1 users had 2-3 more bleeding/spotting days, and a shorter length of bleeding/spotting-free intervals in each period. 63.7%, 41.4% and 60.6% of subjects using Mesigyna, Cyclofem and Injectable No. 1, respectively, had bleeding patterns similar to their untreated patterns in the first 90-day period. The percentages increased to 82.2% 67.8% and 75.0% in the fourth 90-day period. A total of 1815 diaries for Mesigyna and 1802 for Cyclofem were analyzed for more in depth comparison of these two methods. The number of bleeding/spotting days over four periods showed little difference between the two group, but there were more spotting days and there was greater individual variability among Cyclofem users.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1995

Multicenter trial of two monophasic oral contraceptives containing 30 mcg ethinylestradiol and either desogestrel or gestodene in Thai women.

The efficacy and acceptability of two third generation oral contraceptives in Thai women were evaluated in a prospective, open, group-comparative, randomized, multicenter trial of women asking for contraception. In six Family Planning Centers and Outpatient Gynaecological Clinics in urban areas in Thailand, 783 healthy women who were at risk for pregnancy and did not have contraindications to oral contraceptive use were randomly allocated to one of the two study groups. An oral contraceptive containing 30 mcg ethinylestradiol and 150 mcg desogestrel was given to 394 women and an oral contraceptive with the same amount of ethinylestradiol and 75 mcg gestodene to 389 women during 6 cycles. Criteria of cycle control, side effects and the presence and severity of acne vulgaris were assessed and blood pressure and body weight measured at pretreatment and after cycles 1, 3 and 6. Furthermore, the efficacy was evaluated after the last cycle. No pregnancies occurred with either of the contraceptives. The incidences of irregular bleeding and minor side effects in both groups were very low and decreased after an initial increase in the first cycle. Acne improved in both groups. Blood pressure and body weight remained unchanged. The two oral contraceptives were found to be effective and acceptable in Thai women. Compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women. Furthermore, the effects of both oral contraceptives were comparable.

Adult↗
PubMed1995

Levonorgestrel intrauterine device in the treatment of menorrhagia in Chinese women: efficacy versus acceptability.

Ten Chinese women who had menorrhagia without organic cause and suffered from anaemia were treated with levonorgestrel intrauterine device for a total of 129 woman-months. There was a 54%, 87% and 95% reduction in menstrual blood loss at the first, third and sixth month of treatment when compared with the pretreatment cycle. These percentages of reduction were statistically significant, with p values of 0.004, 0.03 and 0.008, respectively. There was a median increase in menstrual cycle length of 12 days in nine months. Fifteen percent of the menstrual cycles were longer than 60 days. The total bleeding days increased by 4 days at the third menstrual cycles, but reduced to a median of 6 days at 6 months. Seventy-six percent of the menstrual bleeding was in the form of spotting. These Chinese women accepted such menstrual alterations. There was no hormonal side effects. All women preferred the device to hysterectomy. Levonorgestrel intrauterine device appeared to be an effective and acceptable treatment for menorrhagia in perimenopausal Chinese women.

Adult↗
PubMed1995

Endometrial morphometry in users of intrauterine contraceptive devices and women with ovulatory dysfunctional uterine bleeding: a comparison with normal endometrium.

Copper-bearing intrauterine contraceptive devices (IUCD) are commonly associated with menorrhagia. They cause certain morphological changes in the endometrium. These have been extensively reported and the mechanisms of menorrhagia have been investigated in a number of studies. By contrast, ovulatory dysfunctional uterine bleeding has not been as widely studied and mechanisms of menorrhagia in these patients are still not well understood. In this study, we examined endometrial morphometry in a group of women using IUCD, a group of women with ovulatory dysfunctional bleeding, and a control group of women with entirely normal cycles. There was increased leukocytic infiltration of the endometrium in both groups of women with menorrhagia compared to control cases. In addition, IUCD use was associated with greater luteal phase glandular epithelial height, supporting the concept of a secretory function defect in glandular epithelium. Possible links are postulated between static morphometric observations and dynamic biochemical changes.

Australia↗
PubMed1995

The influence of the Gyne-T 380S IUD on menstrual blood loss and iron status.

The influence of the Gyne-T 380S intrauterine contraceptive device (IUD) on menstrual blood loss (MBL) and iron status (hemoglobin, hematocrit, red cell count and indices, and serum ferritin) was evaluated. MBL was determined objectively by the alkaline hematin method in 18 women (mean age 37.1 +/- 1.6 yr, range 22-46 yr) before and 3, 6 and 12 months after insertion of a Gyne-T 380S IUD. MBL prior to IUD insertion was 59 +/- 8 ml and increased to 91 +/- 11 ml (p < 0.01) 3 months after insertion. MBL then remained largely unchanged during the remainder of the observation period (6 months, 94 +/- 12 ml; 12 months, 92 +/- 13 ml). The percentage increase in MBL at the respective measurement points ranged between 54 and 59% which is comparable with previous reports regarding the increase in MBL associated with the use of a copper IUD. There were no significant changes recorded in iron status parameters during the 12-month observation period following IUD insertion. Based on the results of the present study, women from developed countries apparently tolerate an increased MBL of approximately 55% without developing iron deficiency anemia. Iron stores were unchanged indicating an adequate adaptive increase in intestinal iron absorption.

Adult↗
PubMed1996

The effect of desogestrel, gestodene, and other factors on spotting and bleeding.

Spotting and bleeding are among the most common side effects associated with oral contraceptive (OC) use and their occurrence is a prime determinant of whether a new user will continue to use OCs. Desogestrel and gestodene are two new progestins that were developed in part to minimize the occurrence of these side effects. Assessing the effect of these progestins is difficult, however, in part because their effects may be subtle, requiring a large sample size and possibly being overshadowed by other factors. To address these issues, we analyzed data from two comparative multicenter clinical trials that included 15,421 cycles among 2767 women. One study compared 75 micrograms gestodene + 30 micrograms ethinyl estradiol (EE) with 150 micrograms desogestrel + 30 micrograms EE, the other compared the same gestodene preparation with 150 micrograms desogestrel + 20 micrograms EE. Both studies found a higher risk of spotting or bleeding in all cycles among users of the desogestrel-containing preparation, with the differences ranging between 20% and 70% higher for the first study and 40% and 140% in the second. These differences were statistically significant in four of six cycles in each study and persisted after controlling for consistency and recency of OC use as well as smoking. After pooling the data and controlling for estrogen dose, the desogestrel-containing preparation was significantly associated with more frequent spotting or bleeding in five of six cycles. Smoking and consistency and recency of OC use were also independent predictors of spotting or bleeding.

Adolescent↗
PubMed1996

Norplant implants in the UK: first year continuation and removals.

Norplant implants are a long-term, reversible hormonal method of contraception consisting of six flexible capsules placed subdermally in the inner aspect of the non-dominant arm. Norplant implants were introduced into the UK in October 1993 although they had been used previously in some countries for up to ten years. The insertion and removal techniques require skills training and therefore it is important to assess early experience with the method. This survey looks at the first year continuation rate of Norplant implants in the UK from a total of 2,129 insertions. From these insertions, 133 removals were documented and described, using a checklist of features. The continuation rate for Norplant implants use was 96.5% at six months and 85.2% at one year. None of the reasons for discontinuation were of a serious nature. The most common reason given was menstrual change (50.4% of all removals, 3% of all women included in the survey), which is in line with other reported studies. Of the removals, 71.5% were reported as straightforward (of these 65.6% were completed within 20 minutes). In the first year of use, Norplant implants were associated with high continuation rates and the removal procedure was, in the majority of cases, completely straightforward.

Capsules↗
PubMed1996

Effect of pretreatment counseling on discontinuation rates in Chinese women given depo-medroxyprogesterone acetate for contraception.

The study examined the effect of pretreatment counseling upon discontinuation of 150 mg depo-medroxyprogesterone acetate (Depo-Provera (DMPA)), given for contraception. A total of 421 Chinese women participated, 204 receiving detailed structured pretreatment and ongoing counseling on the hormonal effects and probable side effects of DMPA and 217 receiving only routine counseling. The primary study endpoint was termination rate; secondary endpoints were frequency of medical events and reasons for termination. Study termination rates were significantly lower in the intensive structured counseling group than in the routine counseling group. At one year, the total cumulative termination rates were 11% (23/204) and 42% (92/217), respectively (p < 0.0001). The most common reasons for terminating DMPA were menstrual changes. No pregnancy, serious or unexpected medical events were reported, nor were statistically or clinically significant changes in vital signs observed. We conclude that pretreatment counseling on expected side effects increases the acceptability of DMPA.

Adolescent↗
PubMed1996

Effects of a sequential regimen of mifepristone-medroxyprogesterone acetate on ovarian function, endometrial development and hormonal parameters.

The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxy-progesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in ten volunteers who were treated for three successive cycles. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on day 21-24 of the third treatment cycle were used to monitor the cycles. Ovulation was confirmed in 11 of the 30 treated cycles and, in these 11, the LH peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding but increased efficacy is needed for phase II clinical trials.

Adult↗
PubMed1996

Menstrual bleeding patterns in Norplant-2 implant users.

The objective of the present study was to analyze the patterns of menstrual bleeding in Singaporean women using Norplant-2 contraceptive implants over a five-year period. Of the 100 women recruited for the study, 62 were still using the implant at the end of five years. Only 9 women discontinued for menstrual reasons and they did so within the first 21 months of implant use. Although a normal menstrual bleeding pattern was uncommon during the first three months of use, 69.4% had normal menstruation at the end of five years. Irregular bleeding was the most common form of menstrual abnormality throughout the study period. Infrequent periods and amenorrhoea were distinctly uncommon, especially after the first two years of use. The pattern of bleeding with Norplant-2 was not significantly different from that previously observed with Norplant.

Adolescent↗
PubMed1981

Oral contraceptive exposure of amenorrheic women with and without prolactinomas.

The purpose of this study was to determine the extent of oral contraceptive (OC) exposure of women with secondary amenorrhea of hypothalamic-pituitary etiology. In 93 of 126 women with secondary amenorrhea sufficient data were obtained regarding menstrual history and OC exposure: 26 patients had evidence of a prolactinoma, an additional 26 patients had idiopathic hyperprolactinemia without evidence of a pituitary tumor, and 41 had "pure" dysfunction hypothalamic-pituitary amenorrhea. After stratification by age at diagnosis and parity the estimated odds ratio for past oral contraceptive usage showed no differences among the three groups (odds ratios between 0.74 and 1.48). Using the chi-square test the proportion of subjects who had regular menses before oral contraceptive intake and developed anovulation immediately after discontinuance ("post pill amenorrhea") in the three groups also showed no difference (x2 = 0.60, P = 0.74). These data indicate that non-ovulatory patients are likely to have been exposed to OC, and do not indicate that patients with prolactinomas differ in the extent of their OC exposure from other specified groups of patients with secondary.

Adenoma↗
PubMed1981

Endocrinologic and psychologic aspects of galactorrhea associated with normal menstrual cycles.

Twelve cases of galactorrhea in women with normal menstrual cycles who were radiologically free of any pituitary adenomas were investigated. Determinations were made for serum thyroid-stimulating hormone (TSH), T3 resin uptake (T3RU), total thyroxine by radioimmunoassay (T4), free thyroxine index (FT4I), norepinephrine, epinephrine, prolactin and urinary luteinizing hormone, total estrogens, pregnanediol and total catecholamines. Psychologic evaluation and assessment were also done using the Middlesex Hospital Questionnaire and the Eysenk, manual dexterity, Bender Gestalt and trial-making scales. Hypothyroidism associated with moderate hyperprolactinemia and anovulation were the main features in eight cases. Associated psychologic disturbances were reported. The other four cases showed significant elevations in serum epinephrine, norepinephrine and urinary total catecholamines with concomitant pathologic scales of anxiety and neuroticism. Thyroxine replacement and psychotherapy are recommended in the treatment of such cases.

Adult↗
PubMed1982

The effect of various oral contraceptive combinations on premenstrual symptoms.

The influence of different oral contraceptives on premenstrual complaints was examined in 191 randomly selected women from an urban population. Premenstrual depression and abdominal swelling was significantly more common in women taking oral contraceptives containing the progestogen component lynestrenol than those containing norgestrel. The reason for this difference is discussed. A deficiency of pyridoxine which affects tryptophan metabolism can explain the difference in premenstrual depression. However, it should be emphasized that the system which controls neuro-endocrine balance is extremely complicated and does not at the present time permit any definite conclusions regarding the influence of oral contraceptives on mental complaints.

Adolescent↗
PubMed1983

Preliminary report on a postpartum CuT 200 study, Santiago, Chile.

An analysis is presented of a study of the Copper-T 200 (CuT 200) intrauterine device at the Barros Luco Hospital in Santiago, Chile. The devices were inserted in 1142 postpartum patients. The expulsion rate was high, 32.1% at 3 months. Of the 372 women who expelled devices, 349 received a replacement CuT 200. The expulsion rate for these reinsertions was 7.7% at 12 months with a continuation rate of 86.4%.

Adult↗