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

This study has been completed.
Sponsor:
Collaborator:
Medley S∕A Indústria Farmacêutica
Information provided by:
Hospital Geral de Fortaleza
ClinicalTrials.gov Identifier:
NCT01174524
First received: December 29, 2008
Last updated: August 2, 2010
Last verified: January 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life in differents phases of menacme [ Time Frame: eleven months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   15 Years to 46 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 29, 2008
Last Updated: August 2, 2010
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Gestodene
Contraceptive Agents
Femovan
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Progestins
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on September 16, 2014