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Query: UMLS:C0018681 (headache)
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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

The efficacy of a new contraceptive delayed-action preparation, Deposiston is reviewed. Deposiston is the estrogen-progestin preparation with predominant estrogen activity. The estrogen and progestin eomponents of the preparation are ehtinyl estradiol and norethindrone acetate, respectively. Contraceptive effect is associated with gonadotropic stimulation by estrogen component, while progestin component provides the thermogenic effect. Mutagenicity, carcinogenicity, and toxicity tests show safety of Deposiston. Clinical trials of Deposiston in 815 women over the period of 16,207 cycles (18.1 cycles/woman) confirm contraceptive efficacy of the preparation: pregnancy occurred in only 12 women. Side effects of Deposiston include nausea (16.06%), vomiting (3.7%), headache (5.08%), and vaginal discharge (11.86%). Each Deposiston package contains 3 white estrogen tablets and 2 red progestin tablets. A woman starts to take Deposiston on day 4 of the cycle: white tablets are taken on days 4, 11, and 18 and 2 red tablets are taken on day 25. On day 2-7 after the red progestin tablets, the woman experiences hemorrhage. Average duration of and the amount of blood loss during the hemorrhage do not differ from those during the normal menstruation. Deposiston is indicated for women with recurrent uterine hemorrhages, gastrointestinal disorders, and decreased libido. The preparation is contraindicated for adolescents younger than 16 years of age, for women with hormonal active tumors, thromboembolism, chronic liver diseases, and idiopathic jaundice.
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PMID:[Hormonal contraception using the oral depot preparation, Deposiston]. 35 70

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

A pilot study was conducted to determine the differences in frequency of physical complaints between 179 Black patients (112 oral contraceptive (OC) users and 67 IUD users) with sickle cell trait (AS) and those without AS. 6 physical complaint types were analyzed: dysmenorrhea; mental depression; vaginal discharge; fatigue; headaches; and nausea-vomiting. Out of 5690 Black patients with hemoglobin AA, 112 OC users and 67 IUD patients with similar age and parity were randomly selected to serve as controls. Cumulative complaint rates (CCR) were measured in comparing the experiences of AS and control patients in the 6 complaint categories. No significant differences between AS and control CCRs at level .05 for any of the 6 complaints were observed for both the OC and IUD groups. For OC users, AS patients reported higher CCR's than control patients for cramps and mental depression while for IUD users, AS patients had higher CCR's for mental depression. The relationship between OCs and mental depression is not clear yet, and further research would benefit AS patients. Another major concern for OC users is the possible development of hypercoagulable state with resultant thromboembolism. Also, evidence suggests that crisis, splenic infarction, and hematuria can develop in AS patients under special conditions; the role of OCs in enhancing the infarctive process in AS patients is not known and needs to be studied further. Further clinical research should also be done to determine the effect of contraception on dysmenorrhea and mental depression in AS patients. AS patients should be observed regularly.
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PMID:Physical complaints of patients with sickle cell trait. 112 75

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

Prolonged intrauterine retention of fetal bone parts is a rare complication of induced abortion, spontaneous intrauterine fetal death, and missed abortion. Here, a case of long-term retention of fetal bone fragments in a 47-year-old Italian women who underwent elective abortion 8 years earlier is reported. The patient was admitted for acute pelvic pain with purulent vaginal discharge. She reported recurrent episodes of abdominal and pelvic pain, meteorism, dysuria, nausea and vomiting, headaches, and irregular cycles with dysmenorrhea and inter menstrual bleeding since the 1979 abortion. Initially, pelvic inflammatory disease was diagnosed and antiphlogistic drugs were prescribed. When symptoms persisted after 10 days of drug treatment, the patient underwent a laparotomy that revealed pyosalpinx with extensive pelvic adhesions. Total hysterectomy with bilateral adnexectomy was performed. The uterine cavity was found to be closely packed with fragments that were determined at stereomicroscopic examination to be pieces of fetal bone. Of particular concern is the potential of this complication to lead to secondary infertility. The retained bone fragments can function similarly to an IUD by producing an increase in the local insertion of prostaglandins and preventing blastocyst implantation. Moreover, the retained fragments are an ideal substrate for bacterial colonization, which can spread to the tubes and destroy the functional integrity of the reproductive apparatus. Retention of fetal bones should thus be considered as a possible etiologic factor in cases of infertility of women with a history of abortion.
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PMID:Prolonged retention of fetal bones: intrauterine device and extrauterine disease. 236 50

A comparative study of Norinyl 1/35 and Brevicon was conducted at the APLAFA clinic in Panama City, Panama. The study sought to evaluate the differences in continuation rates and the frequency of selected side effects which might contribute to method discontinuation. The 300 subjects were randomly allocated to one of the two oral contraceptives. Women in the Brevicon group reported significantly more (p less than 0.05) intermenstrual bleeding, nausea, headaches, dizziness and vaginal discharge than women in the Norinyl 1/35 group. The total discontinuation rate at 12 months was 28.0 for the Norinyl 1/35 group and 46.7 for the Brevicon group, and this difference was significant (p less than .01). Also, significantly more women (p less than .01) in the Brevicon group discontinued for menstrual problems than women in the Norinyl 1/35 group. No pregnancies were reported during this study. While both oral contraceptives appear safe and effective, Norinyl 1/35 was more acceptable to this group of Panamanian women.
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PMID:A comparative study of Norinyl 1/35 versus Brevicon in Panama City, Panama. 344 38

Symptoms related to menstruation are reported in 140 Swiss girls according to postmenarcheal and chronological age. Premenstrual abdominal pains were present in 9-28% of the girls, depending on postmenarcheal age (i.e. years after menarche) (2-30% depending on chronological age). Dysmenorrhoea occurred in 44-64% of the girls according to postmenarcheal age (51-67% according to chronological age). Occasional severe dysmenorrhoea was the type most often reported, by 20-35% of the girls. Large intra-individual and inter-individual variabilities in the occurrence and severity of dysmenorrhoea were observed. The frequency of dysmenorrhoea increased in the first three postmenarcheal years and decreased thereafter. The prevalence of premenstrual headache was low, 0-5%. The frequency of headache during menstruation was 2-11% according to postmenarcheal age (2-19% by chronological age) which was low in comparison with other studies. Severe menstrual headache was more often reported than mild headache. Frequency of severe headache decreased in higher age groups. Other reported symptoms related to menstruation were general discomfort in 1-10% of the girls and premenstrual vaginal discharge in 10-22% according to postmenarcheal age (3-17% according to chronological age). Severe vaginal discharge was more frequent than mild discharge, 8-20% versus 0-3%. The frequency of vaginal discharge increased from the first to the fourth year after menarche.
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PMID:Symptoms related to menstruation in adolescent Swiss girls: a longitudinal study. 403 16

Compilation of recent data on 1130 female volunteers from 17 US sites enrolled in a study of a new low dose combination oral contraceptive (OC) containing .15 mg levonorgestrel and .03 mg ethinyl estradiol are reported. All clients had complete histories and physical examinations at entrance and at 6 month intervals during treatment, and about 20% also had blood sugar, blood urea nitrogen, and liver profile determinations. Follow-up evaluation was performed after the 1st and 3rd cycles and every 3 cycles thereafter to determine patterns of pill taking, bleeding episodes, untoward effects, and concomitant medication. Clients ranged in age from 15-40 with mean age of 23.6; 76.1% were white, 11.9% black, 7.5% Hispanic, and 4.4% Oriental. 61.9% were of proven fertility and 92% had regular cycles. 48.1% of the study population had not used female hormones or been pregnant within 60 days of enrollment. A total of 11,064 cycles over a maximum 31 cycles of treatment are reported. Despite 1-6 or more missed pills in 1623, or 14.7% of the cycles, only 3 pregnancies were reported, only 1 presumed to be a method failure, for a use-effectiveness Pearl index of .35/100 women years of usage. Use of the formulation resulted in a mean cycle length of 28.5 days. 92.7% of cycles ranged from 26-30 days, almost equal to pretreatment values. The frequency of light menstrual flows increased. Breakthrough bleeding was reported in 669 cycles, or 6.0%, while spotting occurred in 852 cycles, or 7.7%. Amenorrhea was reported after 194 cycles (1.8%). No reports of post-pill amenorrhea were made. Incidence of side effects was very low. Only acne, breast discomfort, dysmenorrhea, gastrointestinal symptoms, headache, nausea, and vaginal discharge were reported in more than 1.0% of cycles. The pill had essentially no effect on weight or blood pressure, and produced no clinically significant laboratory abnormalities in hematology, urine, blood sugar, blood urea nitrogen, or liver profile determination. A total of 515 subjects (45.6%) discontinued use of the drug for various nonmedical reasons. Another 146 women (12.9%) discontinued use and gave medical reasons; 132, or 11.7%, were commonly reported side effects of OCs such as breakthrough bleeding, headache, and nausea. Clinical trials with the formulation have shown it to be a safe and effective ultra-low dose combined OC agent whose mode of action is primarily gonadotropin suppression and subsequent anovulation.
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PMID:A new ultra-low-dose combination oral contraceptive. 640 5

The basis for this report is home interviews of users of the contraceptive vaginal ring and the pill from urban and rural clinics in 2 provinces in the Dominican Republic and clinics from 2 towns and a large city in Brazil. Dominican ring users were significantly more likely to be older than pill users, to have more schooling, and have partners with more education. 6% were illiterate and 75% had only elementary education. 1/10 of the ring users reported having had problems with insertion of the ring and 1/5 had problems removing it. It may be worthwhile to try a narrower, more flexible model that may be easier to insert and remove. 1 out of every 6 users reported vaginal odor, 1 out of 8 reported having felt the ring move in their vagina, and 1/3 were aware of the ring at some time. About 1/2 the women in each country said the ring had changed color during use, and about 1/2 of those who reported the change did not like it. It became light gray and looked dirty. Correction may improve acceptance. 10% reported having expelled the ring. Twice as many ring users reported having menstrual problems. Ring and pill users both reported headaches, vaginal discharge, menstrual pain, and increased libido. A large proportion of ring and pill users experienced decreased duration and amount of menstrual bleeding, which was seen more as a beneficial than a negative effect. The same can be said for weight gain, which was "linked" by 89% of the women in the Dominican Republic. 64% of ring users and 67% of pill users described thier respective method as good or very good. Detailed instructions should accompany the final model. They should say that it is alright for the ring to be any place within tha vagina for it to be effective.
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PMID:User's perception of the contraceptive vaginal ring: a field study in Brazil and the Dominican Republic. 641 42


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