Amenorrhea, Dysmenorrhea, Hyperandrogenism, Menstruation Disturbances
Conditions
Keywords
Menstrual irregularity, Menstruation disturbances, Hyperandrogenism
Brief summary
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.
Interventions
DRUGEthinyl Estradiol + Cyproterone acetate
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.
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female subject * Premenopausal subject * 18 years or older * Medical history of irregular menses lasting at least 3 months * Signature of informed consent
Exclusion criteria
* Pregnancy * Use of hormonal contraceptives within 3 months of screening * Primary bilateral oophorectomy * Chemotherapy and / or radiotherapy within 6 months of screening * Hysterectomy * Myotonic dystrophy * Galactosemia * Galactorrhea * History of tuberculosis or schistosomiasis * Elevated prolactin / other significant laboratory alterations * Diabetes * Premature ovarian deficiency * Sensitivity to any component of the drug formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regular Menstruation | Treatment month 3 | Percentage of subjects with regular menstruation at the end of treatment month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual colic | Treatment month 3 | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3. |
| Global self evaluation scores | Treatment month 6 | Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition. |
| Willingness to continue treatment | Treatment month 6 | Percentage of subjects willing to continue treatment with study drug |
| Menstrual flow | Treatment months 3 | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3 |
| Menstrual Flow | Treatment month 4 | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4 |
| Menstrual Colic | Treatment month 4 | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4. |
| Safety | Treatment and follow-up period | Incidence, duration and severity of adverse events, including laboratory tests. |
Countries
Brazil
Outcome results
None listed