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Three sequential oestradiol valerate (E2V) and cyproterone acetate (CPA) combinations based on 11 days of oestrogen and 10 days of oestrogen-progestogen administration were investigated during hormone replacement therapy in two prospective, double-blind randomized trials. Treatment A comprised 2 mg E2V and 1 mg CPA, treatment B, 1 mg and 0.5 mg and treatment C, 2 mg and 2 mg, respectively. During treatment A hot flushes (P < 0.0001), night sweating (P < 0.0001), depression (P = 0.0001), dizziness (P = 0.0001) and insomnia (P = 0.003) decreased significantly. The only side effect was breast tenderness, which was experienced by 18% of the women. Weight and blood pressure, thyroid, adrenal, liver and kidney functions, parathyroid hormone and vitamin D, platelets and blood cell counts did not change during the 12 months of therapy. In the women who received treatment A the menstrual flow became less abundant during the early months of treatment (P < 0.0001), the menses being scanty in around 30% of the women, while some 10% had amenorrhoea. Spotting occurred in 10-20% of the subjects. Endometrial biopsies were atrophic in 10% of the women, whereas a normal secretory phase was observed in 45% and irregular secretion in 45%. After careful analysis using visual analog scales, these findings were interpreted as indicating a high-normal progestational effect. In comparison with the pattern observed in normal menstrual cycles the women who received treatment A had a more heterogenic glandular epithelium, with more papillae, larger stromal cells, a more pronounced decidual reaction and more fibrinoid material. No cases of hyperplasia were seen. Treatment B was less effective than treatment A in relieving climacteric complaints. Irregular bleeding was troublesome in over 20% of cases and amenorrhoea occurred in 50%. Endometrial biopsies were atrophic in 57% of the women. The effectiveness of treatment C in alleviating flushes, sweating, dizziness and depression was the same as that of treatment A. The decrease in menstrual flow during the early months and the incidence of amenorrhoea (approx. 10%) and atrophic endometria (approx. 10%) were comparable. Detailed analysis revealed that C had an even stronger progestational effect than A. It was concluded that A was the treatment of choice in comparison with B and C. It proved highly effective in treating climacteric complaints, had no side effects apart from breast tenderness, provided good cycle control and induced a physiological secretory transformation of the endometrium.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Endometrial effects during hormone replacement therapy with a sequential oestradiol valerate/cyproterone acetate preparation. 838 51

A comparative multicenter clinical trial of two low-dose combined oral contraceptives (OCs) was conducted in Malaysia, Egypt, Thailand, and Mexico. Efficacy, safety and acceptability were investigated in women taking either a norgestrel-based (NG) OC or a norethindrone acetate-based (NA) OC. This paper includes analysis of 892 women, all of whom were at least 42 days but within 26 weeks postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had significantly (p < .05) fewer menstrual-related complaints. Discontinuations due to menstrual problems were significantly more common among NA users (primarily amenorrhea). Discontinuations in the NG group were primarily for other personal reasons, e.g. unable to return to the clinic. There was also a significant difference between the two groups for the 11-month gross cumulative life table discontinuation rates due to menstrual problems (p < .01); the NA group had the higher rate.
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PMID:A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial. 840 8

One single silastic capsule containing nomegestrol acetate, Uniplant, was inserted subcutaneously in 100 women of reproductive age who desired to avoid conception. Insertions and removals of the capsules were made in the gluteal region following intracutaneous local anesthesia with 2% procaine. Eighty women completed one year of use. Eleven women bore the implant for 6-11 months. A total of 1,085 women-months were recorded. One pregnancy occurred, resulting in a Pearl Index of 1.1. Bleeding episodes similar to menstruation occurred in all women but the degree of regularity varied from subject to subject. Amenorrhea developed in the range of 14-18% during the first six months of use but declined to less than 10% during the last six months. Menorrhagia likewise was higher in the first six months (18% in the first month) but fell to less than 10% during the last six months. Spotting was 5% or less. Of the twenty women who did not complete one year of use, nine discontinued because they found other methods were either more practical or less revealing. Three discontinued because of bleeding irregularities, three desired to become pregnant, one became pregnant. Other complaints included dizziness, headache, increased blood pressure, loss of libido, painful breasts and nausea. Over half of the women indicated their desire to continue using the single implant as a contraceptive.
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PMID:One year contraception with a single subdermal implant containing nomegestrol acetate (Uniplant). 843 5

Between April and October 1991 in Baltimore, Maryland, family planning providers tried to follow 246 13-42 year old women at a clinic at the Francis Scott Key (FSK) Medical Center for 3 months who accepted the levonorgestrel-releasing implant Norplant to evaluate its acceptability and effectiveness among a high-risk population. 56% of the women were Black and 41% White. 69% were single. Most were interval gynecologic patients (109), but many were postabortion patients (97). The providers could only follow 108 women. Reasons for unscheduled visits were insertion site tenderness, amenorrhea, and removal. At 1 month, 70 % had at least 1 side effect. 48% had irregular bleeding 1-2 months after insertion. Other side effects included headache (49%), acne (24%), weight gain (22%), increased appetite (19%), and dizziness (18.5%). The 24-hour telephone hotline had only received 38 problem calls, all of which were from FSK Norplant patients. More than 50% of the calls were about menstruation concerns. Reasons for removal included pressure to receive Norplant, increased acne, headaches and prolonged bleeding, and postinsertion site problems. 1 woman became pregnant, but it occurred before insertion. She underwent an abortion and continued to use Norplant. 78% of the women considered Norplant to be excellent and 14% considered it to be good. 95% would recommend it to others. 69% reported convenience to be the best thing about Norplant and 22% said it was pregnancy prevention. Worst things were irregular bleeding (26%) and progestin-related side effects (e.g., headaches and weight gain) (19%). 35% did not consider anything to be bad about Norplant. 64% had at least some apprehension before insertion, the major reasons being fear of needles (48%) and of pain (37%). Prior to insertion, just 37% were worried about potential side effects. The providers thought that the routine follow-up visit at 1 month was not cost-effective and provided no specific clinical benefit. They advocated adequate counseling about side effects to take the place of the follow-up visit.
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PMID:Preliminary experience with Norplant in an inner city population. 844 19

The US Food and Drug Administration finally approved the injectable contraceptive Depo-Provera (DMPA) in October 1992, 25 years after its introduction. Women return to a health facility every 90 days for an intramuscular injection of 150 mg DMPA, which provides them 99% effective contraception. Menstrual changes and spotting are the leading reasons for DMPA discontinuation. Eventually, more than 50% of DMPA users develop amenorrhea. During the first year, women gain about 2 kg and weight increases as time passes. Weight gain is the second leading reason for DMPA discontinuation. DMPA may adversely affect glucose tolerance in women at risk for diabetes, but it does not affect cardiovascular or metabolic functions. It may increase the risk of osteoporosis. A rare side effect is convulsions. 1-10% of DMPA users have other central nervous system effects, such as headaches, dizziness, and depression. Itching and rashes may develop. Fertility returns within 1 year after discontinuation. DMPA is linked to low birth weight. It apparently does not harm breast-fed infants or hinder lactation. A World Health Organization study shows that DMPA users less than 35 years old experience a slight increase in breast cancer but a reduced incidence of endometrial cancer. Nurses are instrumental in guiding women as they choose DMPA and in informing them about its potential side effects, including breast cancer risk. They must screen women for pregnancy and evaluate their risk of breast cancer. They must determine whether women are able to return every 3 months for DMPA injections. Women who select DMPA must use other contraception, e.g., barrier protection, within the first 24 hours after initial injection. Nurses should counsel them about the likely menstrual changes to reduce the likelihood of dissatisfaction. They should recommend a daily dose of 1200 mg of elemental calcium and daily exercise of long bones to minimize the risk of developing osteoporosis.
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PMID:Depo-Provera. 849 47

Quinagolide (QUI) and cabergoline (CAB) are dopamine agonists recently introduced for the treatment of hyperprolactinemia. In the present study, these drugs have been compared in terms of effectiveness and tolerability. Twenty patients (18 females and 2 males) with hyperprolactinemia (8 with microprolactinomas, 6 with idiopathic hyperprolactinemia and 6 with empty sella turcica syndrome) were treated with oral QUI (75 microg once daily) and CAB (0,5 mg twice weekly), in a randomized cross-over trial with placebo between both drugs. Each drug was administered for 12 weeks, separated by other 12 weeks with placebo. PRL levels decreased with both drugs at 2 or 4 weeks of starting the treatment, without differences between both drugs at weeks 4, 8 and 12. At week 12, normal PRL levels (<20 ng/ml) were attained in 90% patients with CAB and only in 75% patients with QUI (p<0.05). After discontinuation of treatment, significant increase in serum PRL was higher after QUI withdrawal than after CAB. Clinical efficacy of both treatments was similar in terms of improvement amenorrhea, oligomenorrhea, galactorrhea, and impotence. All patients completed both cycles of treatment, and the most frequent side-effects were nausea, headache and dizziness, without significant differences between CAB (30%) and QUI (55%). Our study indicates that, at the doses employed here, CAB showed a high percentage of patients with normal PRL at the end of treatment and long-lasting efficacy in the levels of PRL. Clinical response and side-effects were similar in both drugs.
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PMID:A randomized cross-over study comparing cabergoline and quinagolide in the treatment of hyperprolactinemic patients. 1100 66

An autopsy case of a patient with diffuse brainstem glioma associated with Laurence-Moon-(Bardet-)Biedl syndrome is described. The subject was a 25-year-old woman who had been suffering from mental retardation, pigmented retinopathy, obesity, hexadactyly, amenorrhea and renal cysts. She developed dizziness, headache and consequent consciousness disturbance. Magnetic resonance images disclosed marked swelling of the pons without contrast enhancement. By means of combined chemotherapy and radiation, she survived for 15 months. Histopathological diagnosis for postmortem specimens obtained from the brainstem was glioblastoma multiforme. No pathogenetic association between the syndrome and brainstem gliomas is known, and the literature contains no cases of patients with this coincidence.
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PMID:Diffuse brainstem glioma in a patient with Laurence-Moon-(Bardet-)Biedl syndrome. 1118 44

The Norplant system is a long-acting hormonal contraceptive method for women which offers high efficacy. The active principal is levonorgestrel, a progestin widely used in oral contraceptives. The Norplant system is in use in various countries including the US, the Dominican Republic, Colombia, Brazil, Chile, Sweden, and Denmark. Norplant consists of silastic capsules containing levonorgestrel which are inserted subdermally in the arm. The progestin is released in constant form from the moment of implantation. 50 mcg are released daily during the first year and approximately 30 mcg are released in subsequent years. Norplant is effective for at least 5 years if a set of 6 capsules is used. Norplant II, consisting of 2 capsules used for 3 years, has come into use more recently. The cumulative pregnancy rate after 5 years of use by 992 women was 2.7/100 continuous users. The annual pregnancy rate was generally less than .5%. No other reversible method has demonstrated the same level of effectiveness during such prolonged periods of use. The mechanism of action is based on inhibition of ovulation in about 50% of cycles, thickening of cervical mucus, and endometrial suppression. Norplant users may present some adverse effects such as menstrual irregularities, amenorrhea, nausea, dizziness, or headaches, but these symptoms are less frequent than with other hormonal methods. Menstrual irregularity is the most frequent secondary effect and the principal cause of termination of use. The secondary effects are generally acceptable. Follow-up during the period of effectiveness of the implants is simple and infrequent. Norplant is an excellent contraceptive choice for women who do not desire pregnancy but do not wish to use a definitive contraceptive method. Once the implant is removed, fertility rapidly is restored.
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PMID:[Norplant: a new alternative in family planning]. 1217 15

The use of depo-medroxyprogesterone acetate (DMPA), or Depo Provera, has been debated for the 20 years since it became available in 1967. The US Food and Drug Administration (FDA) refused to approve Depo Provera on the basis that it caused breast tumors in a controlled study of Beagle dogs and Rhesus monkeys conducted by Upjohn, the manufacturer. Depo Provera has been approved in over 60 other countries and is in use in 30 or 40 others with an estimated total of almost 5 million users. A natural hormone, progesterone, DMPA is injected intramuscularly and absorbed slowly. Common dosage is 150 mg every 3 months and usually is administered during the 1st week of the menstrual cycle. The pregnancy rate with Depo Provera is .44 pregnancies/100 women years for women receiving 100 mg every 3 months. No pregnancies were recorded in recent studies for women receiving 150 mg. Possible side effects include amenorrhea, weight gain, dizziness and headaches. The median time for contraception after the presumed duration of one's last injection is 5-1/2 months. Some countries only permit women who already have 1 child to use Depo Provera. The FDA in the US approves the use of Depo Provera for treatment of endometrial and renal cancer but accuses it of causing cancer in Beagles and Rhesus monkeys. The studies were conducted over 7 and 10-year periods, respectively, with extremely negative results including the death of 3 dogs due to "drug-induced diabetes," atrophication of adrenal glands, and malignant tumors. There were similar results for the monkey study. In the UK, the Committee for Safety in Medicine supports Upjohn's view that Beagles are unsuitable for comparison testing because "all dogs are acutely sensitive to progesterone." Groups such as the National Women's Health Network, the institute for Food and Development Policy, and "Mother Jones" have used the media to generate opposition to Depo Provera, citing a double standard for rich and poor women, developed and less developed countries. The proponents of Depo Provera criticize health activists for imposing their own standards on women in developing countries. Regarding concerns about greater risk of Acquired Immune Deficiency Syndrome (AIDS), Depo Provera can be injected with disposable needles. In response to the controversy, Upjohn withdrew its application to the FDA in September 1986 but intends to resubmit with new information from a World Health Organization report, which showed no evidence of an increased risk of cancers of the endometrium, liver, or breast.
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PMID:Depo Provera: still controversial. 1217 73

Reactions to oral contraceptive therapy tend to be maximal during the first few months of use. They include nausea or epigastric discomfort, malaise, dizziness, nervousness, fatigue, weakness, leg cramps, headache, and depression. The estrogenic component is thought to be the cause. There may also be a psychogenic basis reflecting apprehension. Breast tenderness is an occasional complaint and intermenstrual spotting or breakthrough bleeding is often reported. Increasing dosage has reduced this symptom. Dysmenorrhea prior to treatment may be improved but occasionally it is aggravated. Drug-induced amenorrhea presents a double problem in that failure to resume medication 7 days after completion of a cycle results in a risk of conception. Episodes of severe uterine bleeding in patients discontinuing use after several months or years have been reported. Other side effects include a skin reaction resembling acne, pruritus, hirsutism, thinning of scalp hair, increased skin pigmentation, and weight gain or loss. Serious vascular complications and hepatic dysfunction have been shown and deviation of thyroid function may be shown by increase of serum protein-bound iodine (PBI). Clinical signs of hyperthyroidism have not been described. Oral contraception is associated with elevated plasma cortisol (hydrocortisone) levels and decreased urinary levels of 17-hydroxycorticosteroids (17-OCHS). Suppression of ovarian activity by oral contraceptives is rapidly reversible. Fear of carcinogenesis has caused much alarm but no proof as of the present time. Safety of long term use will require additional years of experience.
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PMID:Side-effects and possible complications of oral contraceptive drugs. 1225 41


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