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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

The US Food and Drug Administration (FDA) has not approved any injectable contraceptives, but, in December 1990, it approved Norplant, an implantable contraceptive. Family planning providers insert 6 capsules, each with 36 mg levonorgestrel, in a fan shape under the dermis of the upper arm. Norplant protects against pregnancy for at least 5 years . Fecundity returns within 2 weeks after capsules' removal. The steady low levels of levonorgestrel keep down both luteinizing hormone and follicle stimulating hormone levels. It suppresses ovulation and thickens the cervical mucus. Contraindications of Norplant are active thromboembolism, undiagnosed genital bleeding, acute liver disease, liver tumors, and breast cancer. Phenytoin and other drugs which speed up liver metabolism reduce Norplant's efficacy. The leading side effect of Norplant is irregular bleeding patterns. Some less common side effects include headaches, nervousness, dizziness, and acne. First year continuation rates range from 76 to 99% and 25 to 78% for 5 years of use. More than 85% of Norplant users are satisfied. Both continuation and satisfaction are associated with patient counseling. Research and development of biodegradable and other nonbiodegradable implants is ongoing. The most common injectable contraceptive in the world is Depo-Provera. 150 mg of Depo-Provera every 3 months suppresses ovulation, deteriorates the endometrium, thickens cervical mucus, and reduces motility of the tubes, thereby providing adequate protection against pregnancy. Some research shows Depo-Provera use significantly increases the low-density lipoprotein to high-density lipoprotein ratio, thereby increasing the risk for atherogenesis. Effectiveness rates match those of Norplant. Norethindrone enanthate was the first injectable contraceptive. Even though 40 countries approve it, the US does not. Animal studies of injectable microspheres or microcapsules with either progestogen or progestogen and estrogen are in progress.
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PMID:Injectable and implantable contraceptives. 138 11

Panic disorder, a severe anxiety disorder, affects 1-2% of the general population, mostly women 20-40 years old. A 29-year-old married white women with no children presented with an 18-month history of panic attacks. Episodes of abrupt anxiety lasted 5-20 minutes and occurred 3-4 times per week accompanied by rapid heart rate, shortness of breath, dizziness, and a fear of losing control. She was evaluated by a cardiologist several months earlier for episodic tachycardia, but the tests were normal. She was taking .5 mg of lorazepam po 2-3 times per month, which relieved her anxiety. Her only other medication was 1 tablet/day of Triphasal oral contraceptive (OC). She was started on treatment with desipramine 10 mg, and the dose gradually increased to 60 mg/day which she was unable to tolerate because of marked anorexia; lorazepam .5 mg bid and 10.5-mg tablet p.r.n. was continued to address excess activation secondary to the tricyclic depressant. She had changed from a constant dose OC (Lo/Ovral) to a triphasic preparation (Triphasil) 6 months prior to the onset of her panic attacks. The OC was halted, and she has experienced no subsequent panic attacks or avoidance behaviors during 2 years of follow-up. In the 2nd case a 39-year-old married white woman with 3 children presented with a 3-year history of panic attacks. She was given Ortho-Novum 7/7/7 1 tablet/day for about 8 months prior to her 1st panic attack, which occurred while she was driving. Her medications were clorazepate 3.75 mg b.i. d. and Ortho-Novum 7/7/7 1 tablet g.d. for 21 days of each month; she had been taking both since October 1984. Her father and brother had exhibited some driving avoidance behaviors. Because the triphasic OC preparation possible precipitated her panic disorder with agoraphobia, she was changed to Ortho-Novum 1/35 OC which has markedly improved her anxiety for 2 years now.
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PMID:Oral contraceptives and panic disorder. 759 8

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

The mean of the Norplant usage period of 338 acceptors was 44.4 months. Most users had poor education and low incomes; the lower their socioeconomic status, the longer they used the Norplant implant. Return to fertility 3 months after removal was 38.46%; after 6 months, 71.43%; after 9 months, 74.46%; and after 12 months, 75%. The continuation rate at year one was 82.84%; year 2, 74.85%; year 3, 68.34%; year 4, 64.79%; while year 5 was 8.58%. The mean removal time was 21 minutes. There was a very significant difference between trained and untrained removers in the duration of removal. The average number of capsules removed was 5.64. There was no significant difference between trained and untrained removers in successful capsule removal. Reasons for removal were expired date and non-medical complaints such as changing to other contraceptives and the wish to become pregnant; medical complaints were dizziness, vertigo, spotting and amenorrhea. Removal was prompted by acne, metrorrhagia, two or more medical complaints, menorrhagia, physical pain, tenderness at insertion site and spotting. There were no pregnancies found among acceptors. However, 5.92% of the acceptors were pregnant at the time of insertion because of misdiagnosis. It can be concluded that Norplant is effective, safe and acceptable but removal needs trained persons.
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PMID:The Norplant removal training and service at Dr Kariadi Hospital, Semarang, Indonesia. 177 63

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

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

This paper describes the first two years of Norplant use among 1560 acceptors in two rural counties of Hebei province and two rural counties of Shandong province, China. No pregnancies were reported during Norplant use, with an overall continuation rate of 88.4% after two years. Many women did, however, report side effects, including menstrual problems, headache, dizziness, and nausea among 46.7%, 6.7%, 6.3%, and 3.3% of women, respectively. Menstrual cycle disruption accounted for 77% of all Norplant removals. The majority of removals due to menstrual problems occurred in the second year of use, while most of the removals due to other causes occurred during the first year of use. Clinical performance among the four counties was diverse, with two-year continuation rates of 73.9-95.3%. Factors which may contribute to the diversity among study sites and the overall high continuation rate are discussed in the context of Chinese family planning.
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PMID:Introduction of Norplant implants in four counties of rural China: a two-year evaluation. 874 98

A double-blind, randomized controlled trial conducted at 21 centers in 14 countries compared the effectiveness and side effects of the traditional Yuzpe method of emergency contraception (200 mcg of ethinyl estradiol and 1 mg of levonorgestrel divided into 2 equal doses) and levonorgestrel alone (2 doses of 0.75 mg each). 1955 women (979 in the Yuzpe group and 976 in the levonorgestrel group) completed the study. 42 women had subsequent pregnancies, although at least 4 women were pregnant at the time of treatment. The pregnancy rate was 1.1% (95% confidence interval [CI], 0.6-2.0) for the levonorgestrel group and 3.2% (95% CI, 2.2-3.5) for the Yuzpe regimen. The relative risk of pregnancy was 0.36 (95% CI, 0.18-0.70). Levonorgestrel prevented 85% of expected pregnancies while the Yuzpe method prevented only 57%. Efficacy increased when the regimen was initiated within 24 hours and decreased as the time after unprotected intercourse approached 72 hours. Women in the levonorgestrel group reported less nausea, vomiting, dizziness, and fatigue than their counterparts in the Yuzpe group. Overall, 57% of women started bleeding within 3 days of their expected menses and the mean duration of menses of 4.7 days in both groups. Results of this study support use of levonorgestrel alone as an alternative for emergency contraception.
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PMID:Levonorgestrel versus the "Yuzpe" regimen. New choices in emergency contraception. 1009 1

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


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