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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
History of Changes
  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:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

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
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:
Menstruation Disturbances
Amenorrhea
Dysmenorrhea
Hyperandrogenism
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
 Cyproterone
Cyproterone Acetate
Diane
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013