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

August 2, 2010 updated by: Hospital Geral de Fortaleza
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60115290
        • Hospital Geral de Fortaleza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 42 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: gestoden 60 mcg
gestoden 60 mcg, once a day, administered in 24/4 regimen.
Other Names:
  • oral contraceptives
  • quality of life
  • gestodene and ethinyl estradiol
Drug: ethinylestradiol 15 mcg
ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen
Other Names:
  • oral contraceptives
  • quality of life
  • gestodene and ethinyl estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: eleven months
eleven months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life in differents phases of menacme
Time Frame: eleven months
eleven months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Geral de Fortaleza

Collaborators

Medley S∕A Indústria Farmacêutica

Investigators

  • Principal Investigator: joao MM Silva, PhD Student, Hospital Geral de Fortaleza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

August 2, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedleyHGF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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