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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

Prevalence rates of various side effects were studied comparatively among 3 oral contraceptive preparations containing 50 mcg of the estrogen component. Norinyl 1/50, Ovral, and Norlestrin 1 were each randomly assigned to groups of 160 healthy women who had consented to participate in the study designed to quantitate probabilities of experiencing specific side effects and of their continuing into the subsequent cycles. Acne, breast discomfort, nausea, abdominal bloating, headache, fatigue, depression, irritability, vaginal discharge, and breakthrough bleeding were the specific side effects studied; only breakthrough bleedings showed a statistical difference in prevalence. The rate of breakthrough bleeding associated with Ovral use in the 1st 3 cycles (16.6%) was significantly (P .05) lower than that associated with using either Norinyl or Norlestrin (46% and 51.7%, respectively). Norelestrin, aside from breakthrough bleeding, was reported as generally freer of side effects than the other 2 preparations. The probabilities of side effects being experienced in the 2nd or 3rd cycle after the effect(s) was experienced in the 1st cycle showed that overall, for all 3 combination pills, the probabilities significantly decreased from the 2nd to the 3rd cycle (P .05). Also examined was the probability that a side effect would occur in the 2nd or 3rd cycle if the user had not experienced such an effect in the 1st cycle. In each instance, the probabilities are significantly lower (P .05) than the corresponding probabilities where the symptom had been experienced in a previous cycle. These data support the contention that side effects experienced on inititation of oral contraceptives should not prohibit its continuation because the majority of symptoms will disappear as the patient becomes accustomed to the hormonal preparation.
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PMID:The probability of side effects with ovral, norinyl 1/50 and norlestrin. 16 Aug 60

In addition to oral contraceptives (OCs), the morning-after pill, the minipill, and depot preparations also belong to hormonal contraceptives. The latter two contraceptives have not become established among young women because of inadequate cycle control. For postcoital contraception in Austria, Neogynon and Stediril-D, consisting of 0.05 mg of ethinyl estradiol (EE) + 0.25 mg of levonorgestrel, are used within 48 hours of unprotected intercourse. Lower dose OCs have considerably reduced the risks of side effects. Micropills are the optimal OCs with EE under 50 mcg combined with the new generation of gestagens. The beneficial effects include menstrual regularity and the prevention of anemia, ovarian cysts, and fibrocystic mastopathy. Nausea, headache, spotting, and weight gain do occur in individual cases, even among young people. The potential risk of thromboembolism is the most important, although arterial cardiovascular risk is minimal in young age. The probability of postpill amenorrhea is less than 1%. Micropills can be used by young diabetics provided the disease is not beyond 10 years' duration and there is no angiopathy. Acne, seborrhea, and hirsutism are beneficially influenced by a combination of 0.035 mg of EE with 2 mg of cyproterone acetate. The relative risk of endometrial and ovarian cancer are only about half as high among OC users as among nonusers. The risk of breast cancer in young OC users has not been conclusively explained. Regular colposcopy and cytology is recommended for young OC users to preclude the risk of malignancies of the genital tract. Sex education and the use of OCs that are the most suitable and effective for young people can reduce the number of unwanted pregnancies and abortion. The comparison of two 5-year periods in the 1970s and 1980s at the University Obstetrical-Gynecological Clinic in Graz showed that the incidence of births among women under 18 years of age decreased from 3.6% (778) to 1.6% (353).
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PMID:[Benefits and risks of hormonal contraception]. 146 64

A new form of postcoital contraceptive therapy is described as more effective because of reduced incidence of nausea, vomiting, and breast tenderness. Other forms of emergency contraceptive pills (ECPs) are the "Yuzpe" method or high-dose contraceptives. The new method calls for administration of 3 200-mg tablets of danocrine (Danazol) within 72 hours of unprotected intercourse and a second dose 12 hours later. There are mixed reviews of the efficacy of danocrine and ECPs. In one comparative study of ECP and danocrine use, efficacy of danocrine was greater but not significantly so. Another study found danocrine so ineffective that the study was halted. ECP use would not end unintended pregnancies caused by method failure unless it was condom failure. Estimates of ECP use involve 75% of the 1.7 million women with user or method failure, all 1.9 million women with unintended pregnancies from nonuse of contraceptives, and some of the 1.6 million abortion users. An obstacle to ECP use is lack of knowledge due to lack of Food and Drug Administration approval of Ovral and Danazol and physician concern for legal liability. Another obstacle consists in the logistics of obtaining ECPs and the fear of side effects. Provision of ECP kits with 3-5 regimens in clinic or physician offices is proposed for women without contraindications. Anticipated objections are reported to be encouragement of contraceptive risk taking, the health risks of repeated use, restrictions in Title X programs, and the drug effect on fertilization. Another proposal is to sell ECPs as over the counter drugs or in vending machines and changing US contraceptive prescription laws. Objections to elimination of the physician prescription requirement might be an increase in use among women with contraindications and a decrease in regular checkups and Pap tests. The objections could be overcome with proper package labeling. Paternalism is not a sufficient justification for requiring prescription of contraceptives and medical visits. ECPs, in fact, are already available as low dose contraceptives such as Lo/Ovral, Nordette, Levlen, Triphasil, and Tri-Levlen when 4 pills are used. Instructions for ECP use are given.
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PMID:Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. 148 31

Estrogens, gestagens, or estrogen-gestagen combinations can be employed as postcoital oral contraceptives. High dose estrogens, such as 5 mg of ethinyl estradiol (EE) daily for 5 days started at the latest 72 hours after unprotected coitus have been proved quite effective with a failure rate of about 1%. However, in about half of the women nausea and in one=third vomiting occurred. Among gestagens the highly effective 19=testosterone preparations are notable. Most experiences pertain to norgestrel (Razemat) as well as to the twice as effective levonorgestrel (D-(-)-norgestrel) LNG. After unprotected coitus, 0.6 mg of LNG taken within 12 hours but possibly even after 1-3 hours is effective. It is common to use a combination of 0.25 mg of LNG and 0/05 mg of EE (Tetragynon). 2 tablets are taken within 48 hours after unprotected intercourse and 2 more 24 hours later. In 4 large studies in Canada and the US with a total of 1540 women who were given instead of LNG the double dose of the half so effective Razemat, the pregnancy rate was 0.9% (14 pregnancies) and the corrected failure rate was 0.65% after excluding women with several unprotected exposures. Assuming a probability of pregnancy of up to 30% after unprotected intercourse depending on the day of the menstrual cycle, the action of the gestagen=estrogen preparation can be regarded as reliable. The side effects are less frequent compared with the high-dose EE therapy. In an Austrian study of 50 women taking Tetragynon, 11 women had nausea, 2 had breast tension, and 4 had vomiting. The duration of bleeding lasted an average of 2 days longer after the taking the pill. 2 women who vomited 2 hours after taking the 1st Tetragynon dose became pregnant. Therefore, in case of nausea it is recommended that an antiemetic be given, and in case of vomiting, the 1st dose of Tetragynon has to be repeated to assure an effective action.
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PMID:[The postcoital pill]. 150 66

The Norplant System consists of 6 capsules each containing 36 mg of crystal line levonorgestrel (LNG), for a total dose of 216 mg LNG. The capsules are inserted subdermally in the mid-upper arm, and LNG diffuses continuously through the capsule walls for 5 years. In the United States the Norplant System was approved in December 1990. The initial rate of hormone delivery is about 85 mcg/day, then decreases over the next 9 months to 5 mcg/day, and over the ensuing 9 months to 35 mcg/day. Thereafter, the diffusion rate levels off for the next 3.5 years, averaging around 30-35 mcg/day. Removal results in a drop in the plasma concentration of levonorgestrel to below contraceptive levels within 24 hours and below the detectable limit of .1 pg/ml at 96 hours. Preliminarily data from 402 users over 5 years show improvements of Norplant produced better efficacy in all weight classes and a lowered cumulative rate of 1.1 pregnancies of 100 users. The pregnancy rate for the first year of use is 02., better than for oral contraceptives. Side effects include headache, nervousness, nausea, dizziness, dermatitis, acne, change of appetite, breast tenderness, minimal weight gain, some change in hair distribution, and adnexal enlargement. Adverse reactions include breast discharge, possible cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, and vaginitis. More than the usual number of bleeding days occurred in slightly more than one fourth of the patients, prolonged bleeding in 27.6% spotting in 17.1% and amenorrhea in 9.4% of patients. Hyperlipidemic users should be observed for possible low-density lipoprotein elevations. The cumulative discontinuation rate for pregnancy was 3.9 per 100 users; for bleeding irregularities the rate was 25.1 per 100 users, and for other medical results it was about 22.4 per 100 users. Personal reasons for discontinuation accounted for 38.7 per 100 users, equivalent to a cumulative continuation rate of about 30 per 100 users over the 5-year duration.
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PMID:The NORPLANT system of contraception. 168 4

This literature review compares the merits and disadvantages of the levonorgestrel-releasing IUD made by Leiras Pharmaceuticals, Turkey, Finland (LNG-IUD-20), with the Nova-T, Copper-T (TCu) and 220C, and Copper-T-38-Ag (TCu-380Ag). This IUD releases 20 mcg levonorgestrel daily from a Silastic sleeve on the vertical shaft containing 52 mg. The plasma level stabilized after a month at about 0.2 ng/ml, about half as high as that seen with Norplant implants. It is identical in size to the Nova-T. The Cu-T IUDs differ with respect to copper wire or sleeves, or silver-cored wire. The chief studies reviewed here were 2 multi-center trails primarily in European countries, and a 2 large multi-center trials in India. Cumulative pregnancy rates were 0.0 to 0.6 per 100 users for the LNG IUD, compared to slightly higher failures for inert or copper IUDs. While removal rates for bleeding, pain and pelvic inflammatory disease were lower for the LNG-IUD-20, removals for oligomenorrhea, amenorrhea and hormonal side effects were higher than for the other IUDS. In the Indian trials, removals for amenorrhea and irregular bleeding were much higher than rates reported in the European studies, resulting in significantly lower continuation rates overall. The results pointed to district benefits for the LNG-IUD-20, such as lower blood loss and anemia, relief of dysmenorrhea and menorrhagia, as well as possible lower risks of ectopic pregnancy in case of failure, less PID (pelvic inflammatory disease), and the claim by the maker that strictly correct placement is not necessary. Disadvantages of the LNG-IUD-20 are more difficult insertion due to the wider diameter; oligomenorrhea, amenorrhea and irregular bleeding; hormonal side effects such as acne, weight gain, nausea, headache and breast tension; and potential risk of functional ovarian cysts. The LNG-IUD-20 is considered comparable to copper IUDs in effectiveness, safety, longevity, and return to fertility after removal. Users should be counseled that the oligomenorrhea or amenorrhea is neither a medical problem or indicative of infertility, is common for the 1st 2 months, is reversible on removal, may signal an improved hemoglobin profile, relief of dysmenorrhea, and may be preferred to heavy bleeding from other IUDS. The program implications of this IUD are potential lower incidence of ectopic pregnancy and PID. The effect of its use on breast feeding, cost-effectiveness compared to Norplant, in-country manufacture, and cultural acceptance need to be determined in specific locales.
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PMID:An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs. 177 15

A comparison of the triphasic Triphasil and the combined oral contraceptive Diane 50 for treatment of acne for 6 cycles showed significant improvement in both groups. Triphasil (Wyeth-Ayerst) contains 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, 75 mcg levonorgestrel and 40 mcg ethinyl estradiol for 5 days and 125 mcg levonorgestrel and 30 mcg ethinyl estradiol for 10 days. Diane 50 (Schering Ag) contains 2 mg cyproterone acetate and 50 mcg ethinyl estradiol for 21 days per cycle. 10 women in each group had physical, pelvic, ophthalmologic and neurologic exams, hematologic and biochemical screens, assays of free testosterone, sex hormone binding globulin (SHBG), androstenedione, dehydroepiandrosterone SO4 (DHEAS), progesterone, and computations of acne and hirsutism scores. Subjects had used tetracyclines, isotretinoin, erythromycin, topical clindamycin and benzoyl peroxide previously, but were withdrawn from medication in the cycle before the intervention. The mean acne scores, derived from grading and counting lesions and comedones, fell from 63.3 to 6 in the Diane 50 and from 64.2 to 4.5 in the Triphasil group. Subjective results were excellent for 6, good for 2 and unsatisfactory for 2 in the Diane 50 group, and excellent for 8 and good for 2 in the Triphasil group. In both groups mean free testosterone, androgen index, androstenedione and DHEAS, and an increase in SHBG were documented. 5 Triphasil and 5 Diane 50 subjects had increased cholesterol levels during the trial, the only abnormality detected. Side effects reported were recurrence of varicose veins and hemorrhoids in 1 women who withdrew, and complaints of mastalgia, nausea, dysmenorrhea, migraine, headache, backache and vaginal discharge.
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PMID:An open study of Triphasil and Diane 50 in the treatment of acne. 183 45

This is a review of the impact of spinal cord injury on female sexuality, which has received far less attention than male sexuality, and on menstruation, contraception and pregnancy, which have been reported more extensively. The few reports of sexuality in women after spinal cord injury suggests a wide range of adaptability, from 40% to 88% of the subjects achieving satisfactory sexual activity. Some women were able to adapt a positive body image and find new ways of stimulation to orgasm, despite altered body shape, bladder and bowel incontinence, spasticity, and lack of sensation often resulting from spinal injury. The pill, vaginal methods, and IUDs are not recommended, but condoms and possibly Norplant, are appropriate for these women. Menstruation, often ceasing for several months after injury, usually resumes. One study reported lack of menstrual pain, others did not. Many spinal injuries women have achieved 1 or more pregnancies. A few cases have been described of successful pregnancy when the injury occurred during gestation, as has 1 intrauterine death that was successfully delivered by induction. Premature cervical dilatation and labor and small-for-dates infants are more common than usual, but spontaneous abortion are not. Some of the typical problems in pregnancy are urinary tract infections, decubiti, anemia, pedal edema, weight transfer problems, thrombophlebitis, TIA episodes, and nausea. A more serious problem is management of labor, especially if the woman cannot perceive labor pains, or cannot bear down. Frequent check-ups and early hospitalization are recommended. A potentially fatal risk in those injured at T6 or above, is autonomic dysreflexia, stimulated by induction, labor, delivery, or even breast feeding. Autonomic dysreflexia can be treated with epidural anesthesia with lidocaine. Induction is contraindicated. Lactation may cease after 3 months or so because of lack of nipple stimulation.
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PMID:The impact of spinal cord injury on female sexuality, menstruation and pregnancy: a review of the literature. 188 48

The International Planned Parenthood Federation (IPPF) new statement on the diagnosis of pregnancy was drawn up in April 1990. A pregnancy diagnosis includes clinical evaluation of the woman's history, symptoms, physical examination, and pregnancy tests. Pregnancy symptoms may include amenorrhea, nausea, vomiting, enlargement and tenderness of the breasts, frequent urination, and changes in appetite and food and drink habits. If biochemical testing is not possible, a reliable clinical diagnosis of pregnancy cannot take place before 6-8 weeks. At this time, the clinician can observe cervical softening and uterine softening and enlargement if a woman is pregnant. If the uterine size does not match the length of amenorrhea, clinicians should suspect the following: earlier or later conception than indicated, ectopic pregnancy, incomplete or missed spontaneous abortion, twin gestation, hydatidiform mole, or other uterine anomaly. They should suspect ectopic pregnancy in women with smaller than expected uterine size when they have been sterilized or are using an IUD or are using low-dose progestogen-only pills or Norplant. They should refer women with smaller than expected uterine size who are experiencing bleeding and/or pain to a more sophisticated clinical facility, where an accurate diagnosis of and adequate treatment for ectopic pregnancy can be done. Biochemical pregnancy tests consist of antibodies that mark human chorionic gonadotropin (hCG) from a urine or serum sample. hCG levels increase beginning about 10 days after fertilization. The most convenient and inexpensive pregnancy test for clinics is the immunoassay test (slide test), which requires a urine or serum sample. It can provide reliable results a few days after the missed menstrual period. Clinicians should provide appropriate counseling regardless of whether the client wishes to continue or terminate the pregnancy.
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PMID:New IPPF statement on the diagnosis of pregnancy. 192 37


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