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Trial record 8 of 25 for:    gestodene

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

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. Identifier: NCT01174524
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : August 3, 2010
Medley S∕A Indústria Farmacêutica
Information provided by:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

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

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

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

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

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 identifier (NCT number): NCT01174524

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

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Responsible Party: Joao Marcos de Meneses e Silva, MD, Public Health Master, PhD Student, Hospital Geral de Fortaleza Identifier: NCT01174524     History of Changes
Other Study ID Numbers: MedleyHGF
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: January 2009
Keywords provided by Hospital Geral de Fortaleza:
Quality of life
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Contraceptives, Oral
Polyestradiol phosphate
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined