Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

August 5, 2010 updated by: Fundação Educacional Serra dos Órgãos

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Teresópolis, Rio de Janeiro, Brazil, 25976-016
        • Hospital das Clínicas de Teresópolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination 1
Ethinyl Estradiol + Cyproterone acetate
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.
Active Comparator: Combination 2
Ethinyl Estradiol + Cyproterone acetate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regular Menstruation
Time Frame: Treatment month 3
Percentage of subjects with regular menstruation at the end of treatment month 3
Treatment month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual flow
Time Frame: Treatment months 3
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3
Treatment months 3
Menstrual colic
Time Frame: Treatment month 3
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.
Treatment month 3
Global self evaluation scores
Time Frame: Treatment month 6
Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.
Treatment month 6
Willingness to continue treatment
Time Frame: Treatment month 6
Percentage of subjects willing to continue treatment with study drug
Treatment month 6
Safety
Time Frame: Treatment and follow-up period
Incidence, duration and severity of adverse events, including laboratory tests.
Treatment and follow-up period
Menstrual Flow
Time Frame: Treatment month 4
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4
Treatment month 4
Menstrual Flow
Time Frame: Treatment month 5
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.
Treatment month 5
Menstrual Colic
Time Frame: Treatment month 4
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.
Treatment month 4
Menstrual Colic
Time Frame: Treatment month 5
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.
Treatment month 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundação Educacional Serra dos Órgãos

Investigators

  • Principal Investigator: Carlos RB Gama, M.D., Fundação Educacional Serra dos Órgãos
  • Study Director: Carlos P Nunes, M.D., Fundação Educacional Serra dos Órgãos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMI 1-16-08-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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