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Triphasil, a low-dose combination oral contraceptive containing levonorgestrel and ethinyl estradiol, was tested in four Planned Parenthood clinics on 317 women between 18 and 34 years of age (mean, 23) for a total of 4,692 cycles, or 361 woman-years of usage. Approximately half these volunteers (165) were nulligravidas, and 309 (97.5%) were white. Despite instructions on proper tablet usage, there were 416 cycles (8.9%) in which one or more tablets were missed. Only one pregnancy occurred, in a cycle in which a total of four tablets was missed, for an uncorrected Pearl index of 0.28 pregnancies per 100 woman-years of usage. No pregnancy resulted from method failure, indicating a 100% efficacy rate for Triphasil when taken properly. The mean length of the menstrual cycle with Triphasil was 27.9 days; the mean length of menses, 4.4 days; and the mean latency period, 2.1 days. Menstrual flow was average in 64.1% of the subjects, light in 34.1%, heavy in 1.3% and variable in 0.5%. Amenorrhea during the tablet-free interval occurred in only 0.6% of the 4,692 cycles in which Triphasil was used. Breakthrough bleeding occurred in 6.9% of first cycles and 3.2% of total cycles; spotting, in 10.7% of first cycles and 4.4% of total cycles. Other symptoms that occurred with an incidence of greater than or equal to 1% were acne (1.0%), appetite increase (1.2%), breast discomfort (2.8%), breast enlargement (1.3%), gastrointestinal symptoms (1.7%), simple headache (1.4%) and nausea (1.1%). A total of 44 women (13.9%) discontinued treatment for medical reasons.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Planned Parenthood experience with triphasil. 365 99

Synthetic progestins derived from nortestosterone provide a promising contraceptive alternative for women with contraindications for estrogens. Progesterone and synthetic progestins reduce vasodilatation and edema induced by estrogens and stop estrogen-dependent cellular multiplication in target tissue. Progestins have 2 kinds of contraceptive affect: antigonadotropic action at sufficient doses, and peripheral action at lower doses. The cervical mucus is modified in composition and volume, becoming hostile to sperm; the endometrial mucus atrophies; and tubal motility is slowed. High dose progestins are administered from the 5th or 10th to the 25th cycle day, with the earlier date preferred for women with shorter cycles. They are an ideal method for women with endometrial hyperplasia or benign breast disease or histories of breast or uterine cancer, as well as for women over 40 with dysovulatory cycles. Contraindications to high dose progestins include obesity, hypertension, lipid metabolic anomalies, and diabetes. Low dose progestin-only pills are administered at the exact same time each day including during menstruation. They are attractive for some women because they contain no estrogen, a reduced progestin dose causing fewer headaches and less somnolence, and fewer metabolic effects. Low dose progestins are indicated for lactating women, those with contraindications to estrogens such as obesity, hypertension, hyperlipidemia, and diabetes, and those with renal or cardiac insufficiency with valvulopathy. Low dose progestins are also indicated for nulliparas and other women for whom IUDS are contraindicated. Women using low dose progestins should never take drugs that act as enzymatic inductors, which speed hepatic degradation of steroids and reduce their efficiency. A resulting pregnancy is likely to be extrauterine because of slowed tubal transport. The failure rate of low dose progestins ranges from .9-3%, with higher failure rates among younger women. About 30% of users initially experience spotting, which despite its usual disappearance after 2-3 months of use is the most common reason for discontinuing the method. Low dose progestins have no metabolic or vascular effects, but they may cause a relative hyperestrogenism is some users. Other modes of administration of progestin contraception include continuous high doses, never justified solely for contraception. Trimonthly injections of medroxyprogesterone acetate of norethindrone enanthate provide contraception through a long lasting antigonadotropic effect. Metrorrhagia and amenorrhea are among possible side effects. The method is used primarily in developing countries where its ease of use is a major advantage. Subcutaneous implants releasing continuous doses of levonorgestrel provide contraceptive protection for over 5 years. The cumulative failure rate is 1.7 at 5 years. Metabolic tolerance is good. The major side effect is menstrual irregularity.
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PMID:[Progestational contraception]. 365 94

At the Institute of Scientific Investigation of Juarez University of Durango State in Mexico, clinical researchers compared three delivery systems of norethisterone (NET) contraceptive microspheres (biodegradable polymers [e.g., polyglycolic or polylactic acid] containing micronized crystals of NET). In the 6-month system, they injected 800 mg of microspheres containing 200 mg NET intramuscularly into 19 women and then monitored the women for various effects and side effects. Soon after injection, the mean NET level in serum rose to a peak value of about 3 ng/ml and then fell gradually until it was below 0.5 ng/ml at 25 weeks. No pregnancies occurred during this period. Estradiol levels remained well below 100 pg/ml, suggesting inhibition of follicular activity. However, one patient showed an elevation in estradiol at week 16. By 24 weeks, 4 of the 19 women showed signs of the return of follicular activity. Rises in progesterone levels, indicative of ovulation, were not seen in most women during the 6-month period. However, 4 women showed progesterone peaks followed by menstruation in weeks 4, 7, 17, and 23, suggesting that their cycles had begun to return before the end of the 6-month period. 35% of women reported dizziness and nausea. 26% reported nausea. A more serious concern was the disruption seen in the menstrual pattern. 13 women had bleeding and spotting, which continued for 8-30 days in 8 women. In the 3-month system, microspheres containing either 75 or 100 mg NET were injected, each into 5 women. NET levels rose to between 1 and 2 ng/ml and fell to 0.5 ng/ml by week 15. At week 25, they were undetectable. Levels of estradiol remained low for at least 15 weeks as did serum progesterone. No pregnancies occurred. One woman ovulated in week 17. Although no headache, dizziness, and nausea were reported, many of the same disruptions in the menstrual cycle reported in the 6-month study were observed, particularly prolonged cycles, amenorrhea, and spotting. Based on these findings, the researchers deemed the 100 mg for 3 months to be the most safe and effective formulation.
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PMID:Norethisterone contraceptive microspheres. 369 1

A 24-year-old woman presented with progressive optochiasmatic arachnoiditis causing progressively worsening visual loss associated with headache and amenorrhea. Treatment with the standard initial therapy of dexamethasone, warfarin, and dipyridamole was unsuccessful at halting her disease process. Surgical lysis of adhesions led to a temporary improvement and then deterioration. A course of therapy with cyclophosphamide was initiated and her response to this therapy resulted in resolution of her headaches, return of her vision to normal, and resumption of her normal menstrual cycles.
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PMID:Optochiasmatic arachnoiditis with treatment by surgical lysis of adhesions, corticosteroids, and cyclophosphamide: report of a case. 374 28

Lymphoid adenohypophysitis is an autoimmune disorder. Eighteen percent of the multipartums are reported to have autoantibodies to pituitary tissues. The symptoms in lymphoid adenohypophysitis, such as hypopituitarism and sellar tumors, exhibit spontaneous remission. The pituitary is a feasible target organ in other autoimmune diseases of the endocrine system. Of these patients, 19/287 showed a positive immune reaction with pituitary tissue antigens. Our three female patients with sellar and suprasellar mass were clinically diagnosed as having lymphoid adenohypophysitis, because of the spontaneous regression of tumors, or presence of immunologically and endocrinologically abnormal findings. The first case was a 31-year-old woman who had amenorrhea and galactorrhea syndrome for two years after delivery of her second child. CT scan revealed a supraseller enhanced mass lesion. She had concomitant signs of recurrent meningeal irritations. The number of cells in the CSF increased, though the protein concentration increased only slightly. During a one-year close observation, the suprasellar mass spontaneously regressed. The second patient was a 66-year-old woman. In 1945, she underwent hysterectomy and oophorectomy for appendicitis followed by adnexitis. She was admitted because of episodes of headache, vomiting and visual field defect in 1983. CT scan also showed a contrast enhanced mass in the suprasellar region. She had two episodes of high fever. After the treatment with antibiotics and anti-inflammatory agents for 4 months, the tumor disappeared. The third case was a 20-year-old female. She had neither neurological nor endocrinological abnormality, except for attacks of vertigo, nausea and vomiting.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Lymphoid adenohypophysitis, with special reference to 2 cases with sellar tumors spontaneously disappearing on the CT]. 377 4

Four female patients were found to have microadenomas and high prolactin levels, but the symptoms of the syndrome varied among the patients. Three of four patients had overt galactorrhea, obesity, and amenorrhea. One patient was postmenopausal, and another showed menstrual irregularities. Two patients sought medical attention for headaches, and one for visual disturbances. Two patients previously had used psychotropic drugs, and two patients used birth control pills. When tested, all patients had high serum prolactin levels, abnormal sellar tomograms, and the presence of microadenoma of the pituitary was confirmed by computerized tomography.Because of the high incidence of pituitary tumor among these four patients, this study suggests that a complete workup should be done for patients having galactorrhea, amenorrhea, and obesity as a syndrome or as separate entities.
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PMID:Syndrome of galactorrhea, amenorrhea, and obesity as possible indicators of prolactinoma: a case study approach. 380 93

Two cases of pituitary abscesses are reported. The first case was a 22-year-old female who was admitted with 14 months history of intermittent fever and headache followed by amenorrhea and polyuria. Plain craniograms showed no remarkable changes on the sella turcica. Direct coronal CT demonstrated a cystic lesion with a ring-like enhanced capsule in the pituitary complex with the apparent bulging of the pituitary top surface. On dynamic CT, the cystic lesion showed no remarkable increase in density. Transsphenoidal surgery was performed and a purulent materials was drained by cutting the underlying fibrous pituitary tissue. Pathological specimen revealed a marked inflammatory reaction around the degenerative pituitary gland. The second case was a 27-year-old female who underwent transsphenoidal excision of craniopharyngioma on May 12, 1983. Postoperatively she did well with the hormonal replacement therapy until 9 months after surgery when a follow up direct coronal CT revealed a cystic lesion with ring-like enhancement in the pituitary fossa. Purulent material was found at transsphenoidal surgery. Pathological specimen from the hard capsule was a chronic inflammatory fibrous tissue without tumorous component. Over seventy cases of pituitary abscesses have been reported previously, but the majority of them were secondary infections associated with systemic sepsis, chronic sphenoid sinusitis or pituitary tumors. Primary pituitary abscesses were rare and would be difficult to be diagnosed preoperatively without an aid of recent CT technology. Thirty cases in the literature since 1970 are reviewed and its clinical pictures and radiological findings are discussed.
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PMID:[Pituitary abscess: report of two cases and a review]. 380

In preparation for introducing the injectable contraceptive norethisterone enanthate (NET-EN) into the national family planning program, a field study was conducted in 6 family planning clinics in Bangladesh. 3 of the clinics were located in Dhaka, the capital city, 1 was located in a town approximately 15 kilometers from Dhaka, and the other 2 clinics were located several hundred kilometers from Dhaka. A total of 913 women were chosen to receive injections of NET-EN every 8 weeks for 6 months and every 12 weeks thereafter. The mean age of the subjects was 26.8 years, and the mean number of live births was 3.4. The overall cumulative discontinuation rates were 26.3/100 women at 6 months, 37.3/100 at 12 months, and 42.9/100 at 18 months. The most common reason for discontinuing was a disturbance in bleeding. Heavy and/or prolonged bleeding was the single most frequent reason (6.3/100 women at 12 months), but amenorrhea was not uncommon (5.1/100 women at 12 months), while irregular bleeding or spotting was given as a reason somewhat less frequently (3.9/100 women). 3 women became pregnant during the study, giving a cumulative pregnancy rate of 0.4/100 women at 18 months. A variety of complaints fell within the category of "other medical reasons," the most common being fatigue, headache, and dizziness. The overall discontinuation rates varied markedly by center, as did the reasons for discontinuation. The lowest discontinuation rate of 14.7/100 women at 12 months was seen in the Mohammedpur Fertility Services and Training Center. This rate was considerably lower than that in any other center. The highest discontinuation rate was found by the Bangladesh Association for Voluntary Sterilization -- 52.0/100 women at 12 months. The variation in rate of discontinuation because of bleeding disturbances was most dramatic, with relatively high rates at the Bangladesh Association for Voluntary Sterilization, markedly low rates in the Mohammedpur Fertility Services and Training Centre, and intermediate rates elsewhere. Neither the overall discontinuation rate, nor the individual reasons for discontinuation varied much by age group. The most notable finding regarding discontinuation of NET-EN was the marked difference between centers. This is particularly notable given the lack of any major differences with respect to age, parity, residence, and history of contraception of the subjects. These findings suggest that the specific approach used in each clinic had a considerable impact on continuation rates and acceptance of NET-EN.
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PMID:Introduction of the injectable contraceptive NET-EN into family planning clinics in Bangladesh. 387 43

The efficacy and safety of a new triphasic oral contraceptive (OC) were evaluated in a trial involving 120 women ages 18-33 years for a total of 901 woman-months of observation. 1 monthly cycle of this triphasic OC provides 6 tablets of 30 mcg ethinyl estradiol (EE) and 50 mcg levonorgestrel (LNg), 5 tablets of 40 mcg EE and 75 mcg LNg, and 10 tablets of 30 mcg EE and 125 mcg NNg. No pregnancies were reported during treatment. Cycle duration was significantly shorter during than before treatment. Before treatment, 88.6% of subjects had cycles of 29-32 days; after treatment, 74.3% had cycles of 20-28 days. The duration of menstruation was 2-5 days in 96.9% of treatment cycles, and the amount of flow was light to moderate in 94.2%. Breakthrough bleeding occurred in 0.4% and spotting in 1.0% of cycles; there was no amenorrhea. Side effects most frequently reported were headache (13.3%) and dizziness (8.2%). Changes in body weight and blood pressure were minimal.
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PMID:Clinical assessment of a new triphasic oral contraceptive. 391 71

In 103 sexually mature women with disturbance of ovulation, a possible relationship between Kupperman menopausal complaints and endocrinological status was investigated to find the cause of climacteric syndrome. The Kupperman index was increased as the disturbance of ovulation was advanced from the stage of anovulatory cycle to amenorrhea I and further to amenorrhea II. In parallel with the advance in disturbance of ovulation, serum FSH and LH levels rose significantly, and serum estrone (E1) and estradiol (E2) levels dropped. Prolactin (PRL) showed a tendency to decrease. There were some hormonal patterns characteristic of individual complaints; hot flush was associated with increased FSH and LH, and decreased E1 and E2; difficulty in falling asleep, excitability, and fatigability, with increased FSH and LH, and decreased E2; nervousness, with increased LH and decreased E2; headache, with increased LH and PRL, and decreased E2; feeling of cold, with decreased E2 and PRL; and numbness and shoulder stiffness, with decreased E2. In sexually mature women, the complaints associated with abnormal levels of two or more kinds of hormones seemed to be most specifically related with decreased E2, followed by increased LH. Fatigability and headache developed specifically in the ovulatory phase of women with normal menstrual cycles (105 subjects), suggesting that these two complaints are closely related to increased LH. These results indicate that the majority of Kupperman menopausal complaints have their individually specific endocrinological cause, and that they may develop even in sexually mature women if those specific conditions exist. In climacteric syndrome in a narrow sense (i.e., dysautonomic type), each complaint may also have its specific endocrinological cause.
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PMID:[Serum hormone level and Kupperman menopausal complaints in sexually mature women with disturbance of ovulation]. 391 22


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