Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Sponsor

Fundação Educacional Serra dos Órgãos (Other)

Overall Status

Unknown status

CT.gov ID

NCT01103518

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2010

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Regular Menstruation [Treatment month 3]
Percentage of subjects with regular menstruation at the end of treatment month 3

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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