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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01174524
First Posted: August 3, 2010
Last Update Posted: August 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medley S∕A Indústria Farmacêutica
Information provided by:
Hospital Geral de Fortaleza
  Purpose
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.

Condition Intervention Phase
Quality of Life Menopause Contraception Drug: gestoden 60 mcg Drug: ethinylestradiol 15 mcg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

Resource links provided by NLM:


Further study details as provided by Hospital Geral de Fortaleza:

Primary Outcome Measures:
  • Quality of life [ Time Frame: eleven months ]

Secondary Outcome Measures:
  • Quality of life in differents phases of menacme [ Time Frame: eleven months ]

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • gestodene and ethinyl estradiol
  • quality of life
  • oral contraceptives

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174524


Locations
Brazil
Hospital Geral de Fortaleza
Fortaleza, Ceara, Brazil, 60115290
Sponsors and Collaborators
Hospital Geral de Fortaleza
Medley S∕A Indústria Farmacêutica
Investigators
Principal Investigator: joao MM Silva, PhD Student Hospital Geral de Fortaleza
  More Information

Responsible Party: Joao Marcos de Meneses e Silva, MD, Public Health Master, PhD Student, Hospital Geral de Fortaleza
ClinicalTrials.gov Identifier: NCT01174524     History of Changes
Other Study ID Numbers: MedleyHGF
First Submitted: December 29, 2008
First Posted: August 3, 2010
Last Update Posted: August 3, 2010
Last Verified: January 2009

Keywords provided by Hospital Geral de Fortaleza:
Quality of life
Menopause
Contraception

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Gestodene
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Femovan
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Progestins
Contraceptives, Oral, Combined