Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.
J Reprod Med
; 36(4 Suppl): 328-33, 1991 Apr.
Article
en En
| MEDLINE
| ID: mdl-2046081
ABSTRACT
PIP: From August 1988-June 1989, 983 physicians participated in a phase IV trial by following 7759 women using the monophasic oral contraceptive (OC), Demulen 1/35 (1 mg ethynodiol diacetate and 35 ug ethinyl estradiol) to evaluate its efficacy and safety. The total number of cycles for the study stood at 21,440. In addition, the total woman-years stood at 1787. Only 6382 patients could be evaluated for safety. 4.4% of the patients had adverse reactions to the OC, but only 1.7% of all patients stopped taking it. The leading side effects included nausea (67 cases), headache (45), amenorrhea (42), emotional changes (30), breast pain (19), dysmenorrhea (12), and 11 cases of weight gain, abdominal/pelvic pain, and bloating. Of the 280 reported adverse reactions, only 87 (31%) were considered severe. The leading serious adverse reactions were depression (10) and hypertension (6). Only 5412 patients could be used to determine efficacy. The physicians initially reported 121 (2.2%) pregnancies during the study. The researchers learned that 33 of the 84 returned 2nd questionnaires (response rate, 70%) reported that the women conceived after enrollment but before taking the OC. 36 conceived while taking it, but 8 did not take it daily. Noncompliance may have contributed to pregnancy for the remaining 28 cases. Therefore the 36 confirmed pregnancies made for a failure rate of .7%. 85.7% of the pregnancies happened in the 1st 3 months of taking the OC. Either patient noncompliance or true medication failure accounted for treatment failure. Therefore it is important for physicians to instruct patients on how to take OCs correctly.
Palabras clave
Americas; Behavior; Clinical Research; Contraception; Contraception Failure; Contraceptive Agents, Estrogen--contraindications; Contraceptive Agents, Estrogen--side effects; Contraceptive Agents, Female--contraindications; Contraceptive Agents, Female--side effects; Contraceptive Agents, Progestin--contraindications; Contraceptive Agents, Progestin--side effects; Contraceptive Agents--contraindications; Contraceptive Agents--side effects; Contraceptive Effectiveness; Contraceptive Methods--side effects; Contraceptive Usage; Developed Countries; Diseases; Ethinyl Estradiol--contraindications; Ethinyl Estradiol--side effects; Ethynodiol Diacetate--contraindications; Ethynodiol Diacetate--side effects; Family Planning; Human Volunteers; Methodological Studies; North America; Northern America; Oral Contraceptives, Combined--side effects; Oral Contraceptives, Phasic--side effects; Oral Contraceptives--side effects; Ovarian Cysts; Prospective Studies; Research Methodology; Studies; United States; User Compliance
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Anticonceptivos Hormonales Orales
/
Etinilestradiol
/
Diacetato de Etinodiol
Límite:
Adolescent
/
Adult
/
Female
/
Humans
/
Pregnancy
Idioma:
En
Revista:
J Reprod Med
Año:
1991
Tipo del documento:
Article
Pais de publicación:
Estados Unidos