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264 women (about 50% private patients), all less than 40 years old and none with history contraindicating oral contraception, were started on a regimen with Ovral (.5 mg norgestrel and .05 mg ethinyl estradiol). Medication started on Day 5 of a menstrual cycle. Then therapy followed a 3 weeks on, 7 days off schedule. Patients continued for 1-22 cycles (mean 7 cycles) for a total of 1918 cycles. Despite the omission of 42 doses by 32 patients, no pregnancies occurred. The percentages of cycles with average flow, spotting, breakthrough bleeding, and dysmenorrhea were 74.4, 2.5, .4, and .6, respectively. The incidence of amenorrhea, .2%, was spectacularly low in comparison with findings in other studies. Papanicolaou smears (483) were all normal (Class I or II). Morphologic changes seen at endometrial biopsy (61) were similar to those produced by other available progestogen-estrogen compounds. No significant variation from control findings (1878) were found in 1463 laboratory studies. The studies included leukocyte and differential counts (724), and determinations of hemoglobin and hematocrit (388), fasting blood sugar and blood urea nitrogen (114), bilirubin and liver function (61), and renal function (176). Minor symptoms (nausea, vomiting, headache, etc.) were few and disappeared after the first few cycles. The preparation suppresses ovulation (probably through action of the estrogen), probably alters the cervical mucus to inhibit sperm penetration, possibly interferes with nidation, and may interfere with follicular development.
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PMID:Norgestrel, a low dose, oral progestogen for fertility contro. Supplementary report. 564 94

618 women used Ortho-Novum 2mg (2 mg norethindrone and .1mg mestranol) for 5330 cycles of treatment. There were no pregnancies. 34.8% of the patients experienced some diminution of menstrual flow volume and 20.6% experienced bleeding episodes, most commonly during the first few cycles. There was no weight change in 20%, 46.5% noted a gain of 5 to 10 pounds, weight loss occurred in 24.4%. The most common side effects were nausea (2.9%), mastalgia (1.6%), nervousness (1.3%), fatigue (1.1%), and headaches (1.1%). 10.3% of the clinic patients and 14.7% of the private patients complained of side effects. The dropout rate was 5.5%.
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PMID:Long-term study of oral contraception with norethindrone 2 mg. and mestranol 0.1 mg. 590 Oct 12

A total of 835 women in a Swedish multicenter study completed a total of 6472 oral contraceptive (OC) treatment cycles; half of the women were allotted at random to use the monophasic OC Neovletta, also known as Microgynon 30 (30 mcg ethinyl estradiol + 150 mcg levonorgestrel in each tablet) and the 2nd half was allotted to Trionetta, also known as Triquilar, Trigynon, and Logynon (6 tablets with 30 mcg ethinyl estradiol + 50 mcg levonorgestrel, 5 tablets with 40 mcg ethinyl estradiol + 75 mcg levonorgestrel and 10 tablets with 30 mcg ethinyl estradiol + 125 mcg levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 placebo tablets to be used in the otherwise tablet-free interval. There was a comparatively high number of missed tablets. Tablets were omitted in 8.1% of the total number of cycles in the triphasic group and the corresponding figure for the monophasic group was 9.4%. Despite this fact, only 1 pregnancy occurred during the observation period and during treatment with Trionetta 21. This pregnancy was classified by the attending physician as clearly due to patient failure (3 consecutively missed tablets). Both formulations exerted a normalizing effect on cycle length, being more pronounced with the triphasic formulation. The 2 combinations reduced to the same extent previously prolonged bleeding periods, i.e., greater than 7 days. The percentage of women with bleeding periods longer than 7 days in the 6th and 12th treatment cycle was 1.4% and 0.6%, respectively, for Neovletta and 0.9% and 0.6%, respectively for Trionetta. The 2 combinations reduced to the same extent previously profuse bleedings. In the last untreated cycle, the percentage of women with profuse bleeding was 6.7% in the Neovletta group and 9.1% in the Trionetta group. Failure of getting withdrawal bleeding was rare in both treatment groups, but the triphasic formulation was found to be superior to the fixed dose combination. In the Neovletta group 85.9% completed the 1st trial period of 6 cycles. The corresponding figure for Trionetta was 83.9%. Acne and headache were, for both formulations, reported less frequently during treatment than in the last untreated cycle. 1 case of thrombophlebitis was reported during treatment with Neovletta. There was no statistically significant increase of the mean blood pressure or the mean body weight during treatment.
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PMID:Comparison of contraceptive acceptability of levonorgestrel and ethinyl oestradiol administered in one three-phasic (Trionetta) and one monophasic (Neovletta) version. 634 25

Contraceptive vaginal rings (CVRs), with approximate daily release rates of 250-290 mcg of levonorgestrel and 150-180 mcg of estradiol and manufactured in a shell design, were studied for effectiveness and acceptability in multicentered trials involving 1103 ring users in Brazil, Chile, Dominican Republic, Sweden, U.S., Denmark/Finland, and Nigeria. A comparison group of 533 women used the oral contraceptive Nordette. Both 1st and all segment 1 year gross pregnancy rates among CVR users were less than 3/100, rates similar to Nordette users. Continuation at 1 year was 50/100 users of the ring (all segments) and 38/100 among Nordette users, more of whom were lost to follow-up. Gross 1 year rates of termination for medical reasons ranged from 25-29/100. Ring users were more likely to terminate for vaginal problems and pill users for headache, nausea, and associated reasons. These trials indicate that CVRs of this design are as effective and have continuation rates equal to and possibly superior to Nordette under the same study conditions.
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PMID:A multicenter study of levonorgestrel-estradiol contraceptive vaginal rings. I-Use effectiveness. An international comparative trial. 645 8

Although no postcoital method has been developed for safe and effective regular use, postcoital contraception is being offered in Canada and Western Europe on an emergency basis to people who experience such problems as a burst condom. It is little known in the US, however. The 1st commercial version of a postcoital method recently became available to women in England. A former postcoital contraceptive was diethylstilbestrol (DES) which has been linked to cancer in the daughters of women who had taken the drug to prevent miscarriage. A new postcoital contraceptive regime was developed by Albert Yuzpe and consists of 4 ordinary contraceptive pills combining estrogen and progestin to be taken over a 12-hour period. In the US, this is the formulaion of birth control pill marketed under the trade name Ovral by Wyeth Laboratories. England and Germany are the only countries in which the Yuzpe method is officially approved for use as an emergency postocital contraceptive, but the method is used to some degree in most European countries, being well-known in France and Denmark. The most frequent side-effect reported by Yuzpe is vomiting experienced by 29% of women; another 22% felt nauseated. Other side effects, e.g. headache, were infrequent. The findings of the Pregnancy Advisory Service and the Brook Advisory Centre in Britain are reported. Overall very few side effects were found. Postcoital contraceptive treatment may cause the length of the cycle in which it occurs to be irregular. Treatment before day 15 has been found to shorten the cycle, whereas treatment after day 15 lengthens it. The majority of women who become pregnant due to treatment failure tend to seek an abortion. Ectopic pregnancy incidence may also be a result of treatment failure. In 1981, the International Planned Parenthood Federation (IPPF) issued a statement endorsing the use of postcoital contraceptives. Reasons for using them include rape, problems with barrier methods, ineffective use of the pill and IUD expulsion. No drug company in the US has expressed interest in getting FDA approval to market a postcoital contraceptive, partly because its usage might not be widespread. Opposition to approval from groups who believe life begins at conception and consequently that postcoital contraceptives are an abortifacient is expected.
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PMID:Contraception--the morning after. 651 38

The oral contraceptive (OC) Stediril acts by inhibiting ovulation, rendering the endometrium inhospitable to implantation, and rendering the cervical mucus impermeable to sperm. The effectiveness of Stediril may be compromised by failure to follow the dosage schedule: 1 pill daily for 21 days followed by a pill-free interval of 7 days when withdrawal bleeding occurs. Stediril should be taken at a regular time each day. If pills are missed for more than 48 hours, efficacy cannot be guaranteed. If vomiting occurs within 4 hours of pill ingestion, the pill should be replaced. Certain drugs, such as Rifadine, may affect the action of Stediril. Stediril should only be prescribed after a complete medical history and examination, including responding to any questions the patient may have. At a 3-month follow-up visit the patient's tolerance to the drug should be assessed by absence of various symptoms: psychological problems such as nervousness and irritibality that resemble those of pregnancy; skin problems such as acne or changes of pigmentation; periods of nausea that diminish in frequency after a few weeks; weight gain; bleeding problems; or signs of thromboembolic risk, such as headaches, unusual visual disturbances, or hypertension, which require immediate cessation of OC use. Because Stediril constitutes a risk to the fetus in case of unplanned pregnancy, the preliminary gynecological examination is mandatory and the pill should only be prescribed to women able to comply with dosage requirements. The pill should be stopped 6 weeks-3 months before pregnancy to allow the endometrium to regenerate. The carcinogenic role of the pill is frequently discussed but not conclusively proven. Follow-up visits should occur 3 and 6 months after beginning use and every year thereafter.
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PMID:[Stediril]. 656 44

Oviol 22 was administered to 145, and Ovoresta M to 118 healthy female volunteers. During the first six cycles, 27 (18.6%) women discontinued the Oviol 22 intake, and 45 (38,1%) women discontinued the Ovoresta M intake. The other women were observed over 6 cycles. Together, 1,369 cycles were evaluated. Overall, the clinical results with Oviol 22 were more favourable than those with Ovoresta M. The discontinuation rate because of nausea, headache, acne and breast tenderness was lower in the group of women who received Oviol 22 than in the group of women receiving Ovoresta M. Cycle control was much better with Oviol 22 than with Ovoresta M. Following the administration of both preparations, no significant alteration in blood pressure, weight or mental status was seen. None of the patients became pregnant during the period of observation.
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PMID:[Comparison of a 2-phase preparation (Oviol 22) with a low-dose 1-phase preparation (Ovoresta M)]. 657 Jan 17

102 patients using Trinordiol, a triphasic oral contraceptive (OC) containing ethinyl estradiol and d-norgestrel, were followed for 932 cycles in a study of secondary effects. Follow-up visits were scheduled after 1,3, and 6 months and every 6 months thereafter. 26 patients discontinued use of the pills during the study after using them for a total of 159 cycles. 5 discontinued because of abdominal pain, 1 for breast tenderness, and 1 because of headaches or migraines. 7 discontinued because of metrorrhagia, 4 for weight gain, 3 for amenorrhea, 2 for nausea and vomiting, and 1 each for nervousness, water retention, acne, desire for pregnancy, leaving the country, hypertension, and unknown motivation. the average age of patients was 23.6 years, with a range from 14-48. 76% were aged 15-29 years. 52.9% were nulliparas. 58.8% were Belgian, 21.6% were from Mediterranean Europe, 10.8% were Moroccan, and 7.9% were from black Africa. Only 1 patient, a 37 year old, developed hypertension. 15 patients gained more than 2 kg and 17 lost more than 2 kg. 15.8% complained of spotting during the 1st cycle compared to 3.1% during the 6th cycle, 5.2% during cycle 7-12, and 9.1% during cycle 13-30. Among 35 patients who did not discontinue treatment, 7 complained of amenorrhea and 1 of scanty menstrual bleeding, 14 of pain including 7 cases of pelvic pain, 2 of dysmenorrhea, 3 of breast tenderness, and 2 of headaches, 15 of leukorrhea, 3 of nausea, 2 of dizziness, and 1 each of fatigue, acne, galactorrhea, and cutaneous pruritus. 1 case of myoma at the level of the uterine cornu was identified after 24 cycles of treatment. In all, 61 patients had some complaint, while 41 were totally satisfied. No patient became pregnant during the study.
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PMID:[Clinical study of the secondary effects associated with taking a triphasic anti-ovulatory contraceptive]. 670 4

75 patients with cluster headache (63 men and 12 women) and 939 with migraine headache were seen among 1260 new patients at the Princess Margaret Migraine Clinic of Charing Cross Hospital (London, England) over a 16-month period. 3 points of interest emerged from this analysis. The age of onset in women, unlike the men, appeared to be bimodal. Approximately half of the women developed the condition in early adult life, and the remainder at about the time of the menopause. These distributions were significantly different. This was not noted in Ekbom's earlier series nor in that of Pearce, although Ekbom did record a disproportionate number of old women at presentation. Atypical cases seemed more common among women and especially among those women who developed headaches later in life. There were no satisfactory criteria for the classification of less typical cases, e.g., patients with single weekly attacks typical in site and duration, or patients with bout up to 12 attacks daily but with long headache free intervals that would appear to exclude the diagnosis of chronic paroxysmal hemicrania. 6 of the 7 typical premenstrual cases had been on oral contraceptives (OCs), and 4 of these associated breaks from contraception with the start of clusters. They could not abort a cluster by immediately restarting OC. In 1 case there was a temporal association with a change from Ovulen 50 to Ovranette, and the headaches settled when she was changed back to Ovulen 50 3 months later. They recurred when she stopped the Ovulen 50 again after 4 months, and she conceived during the cluster, which ceased in the 4th week of pregnancy. She had another cluster, lasting 6 weeks, which started when she was 11 weeks pregnant but none later in the pregnancy. She had a further cluster 7 months postpartum, and hormonal treatment has been contraindicated by a postpartum thrombosis. The anecdotal nature of this observation cannot be denied, but a large scale trial is not feasible. Longterm OC use, possibly with a 50 mcg estrogen preparation, might be helpful in occasional patients. This phenomenon is the opposite of that found in migraine, emphasizing the distinction between the 2 conditions.
Cephalalgia 1982 Sep
PMID:Cluster headache in women. 715 Nov 51

A case of a young women with paroxysmal nocturnal hemoglobin (PNH) who developed thrombosis of the cerebral veins after beginning a regimen of oral contraceptives is presented. She was 24 years old and presented with a 3-week history of frontal headache, neck stiffness, paraesthesiae of both arms, and weakness of the left leg. She had begun use of Microgynon 2 months before presentation, but had discontinued use when symptoms began. Hematological studies showed a shortened partial thromboplastin time, high fibrinogen and factor VIII levels, and prlonged euglobulin clot lysis time. Though this patient had a history of coagulation difficulties, it was not until after taking the estrogen-containing contraceptive preparation that PNH developed. The mechanism of thrombosis may be related to the liberation of thromboplastic material from hemolysed erythrocytes and to interaction between complement-sensitive platelets and complement components in plasma. It is suggested that the estrogen augmented the previously existing thrombotic condition in this patient, and that administration of estrogen-containing preparations should not occur in women with thrombotic disorders.
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PMID:Cerebral vein thrombosis and the contraceptive pill in paroxysmal nocturnal haemoglobinuria. 744 35


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