Trial | NCT01103518  Report issue

Title

Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
Study Started
Dec 31
2009
Primary Completion
Nov 30
2010
Anticipated
Study Completion
Jan 31
2011
Anticipated
Last Update
Aug 06
2010
Estimate

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.

Combination 1 Experimental

Ethinyl Estradiol + Cyproterone acetate

Combination 2 Active Comparator

Ethinyl Estradiol + Cyproterone acetate

Criteria 

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
No Results Posted