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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01103518
Other study ID # AMI 1-16-08-09
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received April 12, 2010
Last updated August 5, 2010
Start date December 2009
Est. completion date January 2011

Study information

Verified date April 2010
Source Fundação Educacional Serra dos Órgãos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date January 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Ethinyl 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.

Locations

Country Name City State
Brazil Hospital das Clínicas de Teresópolis Teresópolis Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Fundação Educacional Serra dos Órgãos

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regular Menstruation Percentage of subjects with regular menstruation at the end of treatment month 3 Treatment month 3 No
Secondary Menstrual flow Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3 Treatment months 3 No
Secondary Menstrual colic Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3. Treatment month 3 No
Secondary Global self evaluation scores Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition. Treatment month 6 No
Secondary Willingness to continue treatment Percentage of subjects willing to continue treatment with study drug Treatment month 6 No
Secondary Safety Incidence, duration and severity of adverse events, including laboratory tests. Treatment and follow-up period Yes
Secondary Menstrual Flow Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4 Treatment month 4 No
Secondary Menstrual Flow Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5. Treatment month 5 No
Secondary Menstrual Colic Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4. Treatment month 4 No
Secondary Menstrual Colic Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5. Treatment month 5 No
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