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A study comparing 2 triphasic hormonal contraceptive preparations (combinations of ethinyl estradiol and levonorgestrel) is reported. SH B 264 AB was used by 594 women for 6628 cycles with no pregnancies, while 634 women used SH B 261 AB for 6025 cycles with 1 pregnancy. A lower incidence of breakthrough bleeding and spotting was observed among SH B 264 AB users, and this preparation ("Triquilon") is preferred to the other. Triquilon users had a menstrual cycle length of 26-30 days and an amenorrhea rate of .4%. There was a low rate of breakthrough bleedings and spottings, which was higher when patients forgot to take their pills. In the vast majority of Triquilar users, body weight and blood pressure remained constant. Subjective side effects (e.g. nausea, dizziness, headache) were infrequent and decreased as the length of Triquilar use increased. A separate study of 1440 cycles of Triquilar use and 1343 cycles of Microgynon use showed that, while the contraceptive effectiveness was the same, the incidence of breakthrough bleeding and spotting was significantly less frequent among Triquilar users.
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PMID:[The first three-stage preparation for hormonal contraception. Clinical results (author's transl)]. 11 12

Silastic implants containing the progestin, levonorgestrel, were tested as long-term contraceptives in 101 women. After three full years of exposure and 2,998 woman-months of use, no pregnancies had occurred. The continuation rates were 87% at 12 months, 79% at 24 months and 66% at 36 months. The most important side effect was excessive or irregular bleeding during the first year. No treatment was offered for this side effect other than vitamins and iron or change of method, with the exception of 3 cases where ethinyl estradiol was used one time for 2 weeks each. Bleeding disturbances led 8 patients to ask for removal of implants. Other side effects were headache, acne and lower abdominal pain. Blood and urine analysis tested 17 different parameters and all but plasma cortisol remained within normal limits throughout the study. A general tendency toward lowered cortisol values was observed and two subjects had more than one value below the normal limit for the population during the study. Glucose tolerance tests during the second year were abnormal in two women with familial diabetes but they returned to normal values spontaneously at the next test. It is concluded that levonorgestrel implants offer effective protection against pregnancy during the first three years of continuous use. Their acceptability and few side effects justify larger trials, especially if treatment of bleeding irregularities is introduced.
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PMID:A three-year clinical trial with levonorgestrel silastic implants. 38 43

The efficacy of a new estrogen-progestin contraceptive agent Ovidon was evaluated in 65 women. The women were taking the contraceptive for 47 cycles (each Ovidon pill contained 0.25 mg of D-norgestrel and 0.05 mg of ethinyl estradiol). Prior to the Ovidon treatment, 15 women did not use any contraceptive agents or devices, 5 used hormonal contraceptives, 2 used IUDs, 4 used mechanical devices, 20 practiced coitus interraptus, and 9 used a biological method. Ovidon administration provided a 100% contraceptive effect. Side effects of Ovidon included fatigue (15 women), headache (4), irritability (3), fullness of the breast (27), hemorrhage (12), vaginal discharge (6), and changes in libido (22). Ovidon administration did not induce amenorrhea. A 1-3 kg weight gain was observed in 5 women. Laboratory studies showed no changes in hemoglobin levels, leukocyte count, cholesterol, and alkaline phosphatase levels. These findings indicated the safety and contraceptive efficacy of Ovidon.
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PMID:[Clinical trial of the combined contraceptive preparation, Ovidon]. 39 Oct 67

Ovamin 30, a new low-dose oral contraceptive (OC) containing 30 mcg of ethinyl estradiol and 2 mg of ethynodiol diacetate, was evaluated for efficacy and acceptability in a group of women (504 patients; 3236 woman months of use) requesting OCs from their general practitioner. 39 patients withdrew from the study because of side effects which could reasonably be associated with the pill (excessive/irregular bleeding, amenorrhea, depression/headache, and breast discomfort/weight gain), and only 18 of these were menstrual disorders. 12 patients withdrew from the trial to conceive. 1 involuntary pregnancy occurred, and 58 patients were lost to follow-up. An early establishment of acceptable bleeding cycles was maintained in later cycles. The pregnancy rate for this preparation by the Pearl Index was .4/100 woman years with 95% confidence limits of .01-2.24. Ovamin 30 appeared to be an effective and well tolerated low-estrogen OC, and further studies may determine whether side effects are reduced with 30-mcg products as opposed to those containing 50 mcg of estrogen.
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PMID:An open assessment of a new low dose oestrogen combined oral contraceptive. 62 4

Multicenter clinical trial of Ovoresta M, a low-dose combined oral contraceptive containing 0.75 mg lynestrenol and 0,0375 mg ethinyl estradiol, is reported. The trial included 150 women (2,541 treatment cycles). No pregnancies were observed in the group. Bleeding was seen in 95.1% of all treatment cycles between 2-6 days after the last pill was taken, and was not materially different from normal menstruation in 89.3% of cases. Irregular bleeding occurred in 8.1% of cycles. Other side effects included nausea and vomiting, headache, breast fullness, leg circulatory complaints, infections, nervousness, and depression; 140 patients had no previous treatment with oral contraceptives. 2 patients Dropouts included 3 patients who desired to become pregnant, 2 because of irregular bleeding, and 3 others for other reasons. Because of the low dosage of active ingredients the authors consider Ovoresta M a welcome supplement to existing oral contraceptives.
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PMID:[Clinical aspects of a new, very low dose combination contraceptive]. 63 15

Restovar, a low dose combined oral contraceptive containing .75 mg lynestrenol and 37.5 mcg ethinyl estradiol was given to 83 women for up to 25 cycles or 1265 total. A cycle contained 22 pills begun on the first day of menstruation or withdrawal bleeding from previous pill cycles. Each woman was questioned regularly on side effects and bleeding, had weight and blood pressure taken, and received gynecologic exams before and after pill treatment. There were no pregnancies. Latency from end of the cycle to bleeding was 2-3 days in 87%; cycles lasted 28 days in 80%; bleeding lasted 3-4 days in 84%; flow was moderate in 72%; and spotting occurred in 4.2% of cylces and breakthrough bleeding in 2.4%; withdrawal bleeding was absent in 4.2% of cycles. The most common side effects were breast pain in 1.9% of cycles and headaches in 1.2%. These complaints as well as nausea, vomiting, leucorrhea, nervousness and depression were reported as less frequent or absent more often than present or aggravated. 6 women quit for drug related reasons. There was no significant weight change or hypertension (means 126/82 and 120/80 before and during Restovar. Thus this low dose pill is remarkably effective and well tolerated.
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PMID:[Clinical study of restovar, an oral contraceptive with a low estrogen content]. 114 76

Pregnon is a new low-dosage ovulation-inhibiting agent containing 1 mg of lynestrenol and .05 mg of ethinyl estradiol in each tablet. It is also marketed under the name of Pregnon 28 or Ovostat 28 in which each package contains 22 active plus 6 placebo tablets. Data were collected from Belgian clinics and evaluated by the Medical Unit of Organon in Belgium and the Netherlands. During this study, 639 women of fertile age were monitored through 9159 cycles. The maximum period of treatment was 36 cycles. Clinical and gynecological examinations were made before treatment and then every 2 or 3 months. Treatment was begun by taking the 1st tablet on the 1st day of menstruation. After taking 22 tablets there was a 6-day tablet-free interval during which withdrawal bleeding usually occurred. The intensity of the withdrawal bleeding was normal in 57.3%, slight in 41.7%, and heavy in 1%. Spotting was noted in 3.1% of the cycles and breakthrough bleeding occurred in 2.9%. Usually they occurred in the first 3 cycles. Amenorrhea was observed in 2.9% of the cycles. Body weights were relatively unchanged. Blood pressures remained the same. Side effects were headache, nausea, vomiting, breast tenderness, heavy legs, leucorrhea, nervousness, depression, and decreased libido. Only 46 patients discontinued treatment because of these drug effects yielding an acceptability level of about 93%. Since no pregnancies occurred during this study, the Pearl index was 0.
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PMID:Clinical evaluation of a new oral contraceptive, 'Pregnon'. 114 83

A clinical review of the oral contraceptive Ovral (.5 mg norgestrel, .05 mg ethinyl estradiol), representing 6806 users over 9836 woman-years of use, is presented. 19 pregnancies occurred (.19 per 100 woman-years), though none were attributable to failure of the drug. Menstrual periods were regular and predictable in at least 80% of the patients. The incidence of intermenstrual bleeding was low (2.5% of the cycles). 306 patients (4.5%) discontinued medication for medical reason s, the most prevalent of which were headache, nausea and vomiting, weight gain, and nervousness. Breast masses developed in 19 women, carcinoma in situ of the cervix in 16 patients, and thrombophlebitis in 9 women. Hepatic and thyroid functions were slightly altered, though there was no evidence of abnormal adrenal function or neuro-ophthalmologic effects related to the medication. Fertility promp tly returned after cessation of treatment in most cases, and no infant a bnormalities were attributable to the drug. The contraceptive effect of Ovral is suggested to be due primarily to gonadotropin suppression with subsequent inhibition of ovulation.
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PMID:Eight years of fertility control with norgestrel-ethinyl estradiol (Ovral): an updated clinical review. 118 25

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
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PMID:Clinical experience with a new norgestimate-containing oral contraceptive. 134 20

Oral contraceptive (OC) use is a risk factor for developing deep venous thromboses (DVT) in adolescents, especially among those undergoing surgery. OCs increase venous distensibility, affect the intimal proliferation of venous walls, and increase blood coagulability. All of these factors affect thrombus formation. Adolescent females frequently use OCs to meet contraceptive and noncontraceptive ends. This paper describes the development of a DVT in a 17-year old female presenting for elective surgery to correct recurrent shoulder subluxation. Up to the day of admission, this patient used OCs containing 35 or 50 mcg ethinyl estradiol and 1.0 mcg norethindrone. She denied having chest pain, leg pain, hemoptysis, and headaches. There was no history of extended bed rest before surgery and no family history of thromboembolic disease. The operation was conducted without event. Nevertheless, the patient developed a DVT in the left popliteal vein. which was resolved with supportive measures and anticoagulation therapy using heparin and coumadin. Adolescent females using OCs should not take contraceptive pills for at least 1 month before and after elective surgery and attendant immobilization. Contraceptive counseling should be provided for these youths to help them adopt another form of contraception over this minimal 2-month period. Associated literature is briefly reviewed.
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PMID:Oral contraceptives and venous thromboses in adolescents undergoing elective surgery: a case report, and review of the literature. 142 Feb 20


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