Clinical assessment of ethinylestradiol and cyproterone acetate in menstrual irregularities of hyper-androgenic origin
| Autor: | Gama, Carlos Romualdo Barbosa [UNESP], Gama, Gustavo Falcão, Lasmar, Ricardo Basil, Fonseca, Rogerio Sergio, Guimarães, Lucia Cunegatto, De Aquino, Sabrina, Geller, Mauro, Ribeiro, Rachel Leite |
|---|---|
| Přispěvatelé: | FMT-UNIFESO, Universidade Estadual Paulista (Unesp), Hospital Mário Pena, UFF, Instituto Fernandes Figueira, Serviço de Ginecologia do HCTCO, Centro Universitário Serra Dos Órgãos, UNIFESO, Instituto de Pós-Gradução Médica Carlos Chagas, Universidade Federal do Rio de Janeiro (UFRJ), Universidade do Estado do Rio de Janeiro (UERJ) |
| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
libido
double blind procedure drug safety patient satisfaction side effect gastrointestinal symptom cyproterone acetate dysmenorrhea patient compliance menstrual cycle amenorrhea pelvic erythema Ethinylestradiol abdominal erythema chloasma oral contraceptive agent controlled study human leg edema menstrual irregularity sleep disorder controlled clinical trial adult clinical trial vital sign major clinical study body mass breakthrough bleeding drug efficacy female glucose blood level breast tenderness randomized controlled trial drug synthesis withdrawal bleeding asthenia menstruation Hyperandrogenism drug induced headache erythema mood change |
| Zdroj: | Scopus Repositório Institucional da UNESP Universidade Estadual Paulista (UNESP) instacron:UNESP |
| Popis: | Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:24:47Z No. of bitstreams: 0 Made available in DSpace on 2014-05-27T11:24:47Z (GMT). No. of bitstreams: 0 Previous issue date: 2010-09-01 We report on the results of a double-blind, randomized, controlled clinical trial comparing two preparations of ethinylestradiol and cyproterone acetate in the treatment of women of reproductive age presenting menstrual irregularities of hyper-androgenic origin. After obtaining informed consent, subjects were randomized to a 4-month treatment period consisting of one daily dose of 0.035mg ethinylestradiol + 2mg cyproterone acetate. The treatment regimen cycle consisted of one pill, once daily for 21 days, followed by a 7-day pill-free period. We compared the efficacy of two presentations of the drug combination after each treatment cycle (Visits 2, 3, 4, and 5) in establishment and maintenance of menstrual regulation, intensity of menstrual flow, and dysmenorrhea, as well as a comparison of the two presentations in terms of Global Satisfaction and Drug Satisfaction assessments performed by the patients and the investigating physician. At each study visit, drug compliance and use of concomitant medications, as well as incidence, severity and duration of adverse events were recorded. A total of 86 subjects were randomized to treatment, with 43 subjects in each treatment group. At Visit 2 and each subsequent visit, all patients in both treatment groups reported an episode of withdrawal bleeding during the 7-day hormone-free period. We observed a statistically significant (p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|