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

Phase 4

Completed

• Conditions: Quality of Life; Menopause; Contraception
• Interventions: Drug: gestoden 60 mcg; Drug: ethinylestradiol 15 mcg

• Registration Number: NCT01174524
• Lead Sponsor: Hospital Geral de Fortaleza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-12-29
• Status Verified: 2009-01
• Study First Submitted QC: 2010-08-02
• Last Update Submitted: 2010-08-02
• Study First Posted: 2010-08-03
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gestoden and ethinylestradiol	ethinylestradiol 15 mcg	Gestoden 60 mcg plus ethinylestradiol 15 mcg, once a day, administered in 24∕4 regimen, for three months. The use of gestoden and ethinylestradiol can do an improvement of the quality of life before and after the use of the drug.Numerous large clinical trials have shown that this combination is as effective in preventing pregnancies as other oral contraceptives presently on the market. Irregular bleeding and spotting rates appear to be at least as good as older formulations. In general, the incidence of side effects associated with the progestin and estrogen components tends to be low, with very little impact on lipid and carbohydrate metabolism. . For this, the regimen can ameliorate the quality of life of the patients.
gestoden and ethinylestradiol	gestoden 60 mcg	Gestoden 60 mcg plus ethinylestradiol 15 mcg, once a day, administered in 24∕4 regimen, for three months. The use of gestoden and ethinylestradiol can do an improvement of the quality of life before and after the use of the drug.Numerous large clinical trials have shown that this combination is as effective in preventing pregnancies as other oral contraceptives presently on the market. Irregular bleeding and spotting rates appear to be at least as good as older formulations. In general, the incidence of side effects associated with the progestin and estrogen components tends to be low, with very little impact on lipid and carbohydrate metabolism. . For this, the regimen can ameliorate the quality of life of the patients.

Primary Outcome Measures

Name	Time	Method
Quality of life	eleven months

Secondary Outcome Measures

Name	Time	Method
Quality of life in differents phases of menacme	eleven months

Trial Locations

Locations (1)

Hospital Geral de Fortaleza; 🇧🇷 Fortaleza, Ceara, Brazil