Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Fundação Educacional Serra dos Órgãos.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fundação Educacional Serra dos Órgãos
ClinicalTrials.gov Identifier:
NCT01103518
First received: April 12, 2010
Last updated: August 5, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Amenorrhea
Dysmenorrhea
Menstruation Disturbances
Hyperandrogenism
Drug: Ethinyl Estradiol + Cyproterone acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin

Resource links provided by NLM:


Further study details as provided by Fundação Educacional Serra dos Órgãos:

Primary Outcome Measures:
  • Regular Menstruation [ Time Frame: Treatment month 3 ] [ Designated as safety issue: No ]
    Percentage of subjects with regular menstruation at the end of treatment month 3


Secondary Outcome Measures:
  • Menstrual flow [ Time Frame: Treatment months 3 ] [ Designated as safety issue: No ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3

  • Menstrual colic [ Time Frame: Treatment month 3 ] [ Designated as safety issue: No ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.

  • Global self evaluation scores [ Time Frame: Treatment month 6 ] [ Designated as safety issue: No ]
    Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.

  • Willingness to continue treatment [ Time Frame: Treatment month 6 ] [ Designated as safety issue: No ]
    Percentage of subjects willing to continue treatment with study drug

  • Safety [ Time Frame: Treatment and follow-up period ] [ Designated as safety issue: Yes ]
    Incidence, duration and severity of adverse events, including laboratory tests.

  • Menstrual Flow [ Time Frame: Treatment month 4 ] [ Designated as safety issue: No ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4

  • Menstrual Flow [ Time Frame: Treatment month 5 ] [ Designated as safety issue: No ]
    Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.

  • Menstrual Colic [ Time Frame: Treatment month 4 ] [ Designated as safety issue: No ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.

  • Menstrual Colic [ Time Frame: Treatment month 5 ] [ Designated as safety issue: No ]
    Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103518

Locations
Brazil
Hospital das Clínicas de Teresópolis
Teresópolis, Rio de Janeiro, Brazil, 25976-016
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Prof. Carlos Romualdo Barboza Gama, Fundação Educacional Serra dos Órgãos
ClinicalTrials.gov Identifier: NCT01103518     History of Changes
Other Study ID Numbers: AMI 1-16-08-09
Study First Received: April 12, 2010
Last Updated: August 5, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Fundação Educacional Serra dos Órgãos:
Menstrual irregularity
Menstruation disturbances
Hyperandrogenism

Additional relevant MeSH terms:
Amenorrhea
Dysmenorrhea
Hyperandrogenism
Menstruation Disturbances
46, XX Disorders of Sex Development
Adrenogenital Syndrome
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Gonadal Disorders
Pain
Pathologic Processes
Pelvic Pain
Signs and Symptoms
Urogenital Abnormalities
Cyproterone
Cyproterone Acetate
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Polyestradiol phosphate
Androgen Antagonists
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Estrogens
Hormone Antagonists

ClinicalTrials.gov processed this record on October 23, 2014