Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01103518
• Other study ID #: AMI 1-16-08-09
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 12, 2010
• Last updated: August 5, 2010
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2010
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amenorrhea
• Dysmenorrhea
• Hyperandrogenism
• Menstruation Disturbances

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Teresópolis	Teresópolis	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regular Menstruation	Percentage of subjects with regular menstruation at the end of treatment month 3	Treatment month 3	No
Secondary	Menstrual flow	Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3	Treatment months 3	No
Secondary	Menstrual colic	Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.	Treatment month 3	No
Secondary	Global self evaluation scores	Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.	Treatment month 6	No
Secondary	Willingness to continue treatment	Percentage of subjects willing to continue treatment with study drug	Treatment month 6	No
Secondary	Safety	Incidence, duration and severity of adverse events, including laboratory tests.	Treatment and follow-up period	Yes
Secondary	Menstrual Flow	Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4	Treatment month 4	No
Secondary	Menstrual Flow	Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.	Treatment month 5	No
Secondary	Menstrual Colic	Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.	Treatment month 4	No
Secondary	Menstrual Colic	Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.	Treatment month 5	No