Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

NCT01103518 | Unknown Phase 4

• 1 other identifier: AMI 1-16-08-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amenorrhea; Dysmenorrhea; Menstruation Disturbances; Hyperandrogenism

Keywords

Menstrual irregularity; Menstruation disturbances; Hyperandrogenism

Outcome Measures

Primary Outcomes (1)

• Regular Menstruation

  Percentage of subjects with regular menstruation at the end of treatment month 3

  Treatment month 3

Secondary Outcomes (9)

• Menstrual flow

  Treatment months 3

• Menstrual colic

  Treatment month 3

• Global self evaluation scores

  Treatment month 6

• Willingness to continue treatment

  Treatment month 6

• Safety

  Treatment and follow-up period

Study Arms (2)

Combination 1

EXPERIMENTAL

Ethinyl Estradiol + Cyproterone acetate

Drug: Ethinyl Estradiol + Cyproterone acetate

Combination 2

ACTIVE COMPARATOR

Ethinyl Estradiol + Cyproterone acetate

Drug: Ethinyl Estradiol + Cyproterone acetate

Interventions

Ethinyl Estradiol + Cyproterone acetate DRUG

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; Combination 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subject
• Premenopausal subject
• years or older
• Medical history of irregular menses lasting at least 3 months
• Signature of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

Study Sites (1)

Hospital das Clínicas de Teresópolis

Teresópolis, Rio de Janeiro, 25976-016, Brazil

Location

MeSH Terms

Conditions

Amenorrhea; Dysmenorrhea; Menstruation Disturbances; Hyperandrogenism

Interventions

Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Carlos RB Gama, M.D.

  Fundação Educacional Serra dos Órgãos

  PRINCIPAL INVESTIGATOR

• Carlos P Nunes, M.D.

  Fundação Educacional Serra dos Órgãos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: December 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 6, 2010

Record last verified: 2010-04

Locations

BR (1)