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This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination 1 | Experimental | Ethinyl Estradiol + Cyproterone acetate |
|
| Combination 2 | Active Comparator | Ethinyl Estradiol + Cyproterone acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinyl Estradiol + Cyproterone acetate | Drug | Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Regular Menstruation | Percentage of subjects with regular menstruation at the end of treatment month 3 | Treatment month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3 | Treatment months 3 |
| Menstrual colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos RB Gama, M.D. | Fundação Educacional Serra dos Órgãos | Principal Investigator |
| Carlos P Nunes, M.D. | Fundação Educacional Serra dos Órgãos | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas de Teresópolis | Teresópolis | Rio de Janeiro | 25976-016 | Brazil |
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| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| D004412 | Dysmenorrhea |
| D008599 | Menstruation Disturbances |
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
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| Treatment month 3 |
| Global self evaluation scores | Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition. | Treatment month 6 |
| Willingness to continue treatment | Percentage of subjects willing to continue treatment with study drug | Treatment month 6 |
| Safety | Incidence, duration and severity of adverse events, including laboratory tests. | Treatment and follow-up period |
| Menstrual Flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4 | Treatment month 4 |
| Menstrual Flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5. | Treatment month 5 |
| Menstrual Colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4. | Treatment month 4 |
| Menstrual Colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5. | Treatment month 5 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |