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Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Primary Purpose

Amenorrhea, Dysmenorrhea, Menstruation Disturbances

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Ethinyl Estradiol + Cyproterone acetate

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring Menstrual irregularity, Menstruation disturbances, Hyperandrogenism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Hospital das Clínicas de Teresópolis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination 1

Combination 2

Arm Description

Ethinyl Estradiol + Cyproterone acetate

Outcomes

Primary Outcome Measures

Regular Menstruation

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

Secondary Outcome Measures

Menstrual flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3

Menstrual colic

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.

Global self evaluation scores

Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.

Willingness to continue treatment

Percentage of subjects willing to continue treatment with study drug

Safety

Incidence, duration and severity of adverse events, including laboratory tests.

Menstrual Flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4

Menstrual Flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.

Menstrual Colic

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.

Menstrual Colic

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.

Full Information

NCT ID

NCT01103518

First Posted

April 12, 2010

Last Updated

August 5, 2010

Sponsor

Fundação Educacional Serra dos Órgãos

1. Study Identification

Unique Protocol Identification Number

NCT01103518

Brief Title

Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

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 Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

November 2010 (Anticipated)

Study Completion Date

January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fundação Educacional Serra dos Órgãos

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism

Keywords

Menstrual irregularity, Menstruation disturbances, Hyperandrogenism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination 1

Arm Type

Experimental

Arm Description

Ethinyl Estradiol + Cyproterone acetate

Arm Title

Combination 2

Arm Type

Active Comparator

Arm Description

Ethinyl Estradiol + Cyproterone acetate

Intervention Type

Drug

Intervention Name(s)

Ethinyl Estradiol + Cyproterone acetate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Regular Menstruation

Description

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

Time Frame

Treatment month 3

Secondary Outcome Measure Information:

Title

Menstrual flow

Description

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3

Time Frame

Treatment months 3

Title

Menstrual colic

Description

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.

Time Frame

Treatment month 3

Title

Global self evaluation scores

Description

Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.

Time Frame

Treatment month 6

Title

Willingness to continue treatment

Description

Percentage of subjects willing to continue treatment with study drug

Time Frame

Treatment month 6

Title

Safety

Description

Incidence, duration and severity of adverse events, including laboratory tests.

Time Frame

Treatment and follow-up period

Title

Menstrual Flow

Description

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4

Time Frame

Treatment month 4

Title

Menstrual Flow

Description

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.

Time Frame

Treatment month 5

Title

Menstrual Colic

Description

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.

Time Frame

Treatment month 4

Title

Menstrual Colic

Description

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.

Time Frame

Treatment month 5

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos RB Gama, M.D.

Organizational Affiliation

Fundação Educacional Serra dos Órgãos

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlos P Nunes, M.D.

Organizational Affiliation

Fundação Educacional Serra dos Órgãos

Official's Role

Study Director

Facility Information:

Facility Name

Hospital das Clínicas de Teresópolis

City

Teresópolis

State/Province

Rio de Janeiro

ZIP/Postal Code

25976-016

Country

Brazil

12. IPD Sharing Statement

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Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

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