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NCT01174524 Clinical Trial

Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

Quality of Life Clinical Trial

Official title:
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01174524
Other study ID # MedleyHGF
Secondary ID
Status Completed
Phase Phase 4
First received December 29, 2008
Last updated August 2, 2010
Start date January 2008
Est. completion date November 2008

Study information
Verified date January 2009
Source Hospital Geral de Fortaleza
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics CommitteeBrazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 46 Years
Eligibility Inclusion Criteria:

- Fertile women with indication of use of contraceptive pills

Exclusion Criteria:

- Fertile women with any surgical contraceptive method

- Women in menopause

- Diseases the forbidden the use of the drug

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gestoden 60 mcg
gestoden 60 mcg, once a day, administered in 24/4 regimen.
• ethinylestradiol 15 mcg
ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen

Locations
Country Name City State
Brazil Hospital Geral de Fortaleza Fortaleza Ceara

Sponsors (2)
Lead Sponsor Collaborator
Hospital Geral de Fortaleza Medley S/A Indústria Farmacêutica

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life eleven months Yes
Secondary Quality of life in differents phases of menacme eleven months Yes
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