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

NCT ID: NCT01174524

Last Updated: 2010-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Quality of Life Menopause Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gestoden and ethinylestradiol

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.

Group Type EXPERIMENTAL

gestoden 60 mcg

Intervention Type DRUG

gestoden 60 mcg, once a day, administered in 24/4 regimen.

ethinylestradiol 15 mcg

Intervention Type DRUG

ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen

Interventions

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gestoden 60 mcg

gestoden 60 mcg, once a day, administered in 24/4 regimen.

Intervention Type DRUG

ethinylestradiol 15 mcg

ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen

Intervention Type DRUG

Other Intervention Names

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oral contraceptives quality of life gestodene and ethinyl estradiol gestodene and ethinyl estradiol quality of life oral contraceptives

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medley S∕A Indústria Farmacêutica

UNKNOWN

Sponsor Role collaborator

Hospital Geral de Fortaleza

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hospital Geral de Fortaleza

Principal Investigators

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joao MM Silva, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Hospital Geral de Fortaleza

Locations

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Hospital Geral de Fortaleza

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MedleyHGF

Identifier Type: -

Identifier Source: org_study_id

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