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

• Sponsor: Hospital Geral de Fortaleza (Other)
• Overall Status: Completed
• CT.gov ID: NCT01174524
• Collaborator: Medley S∕A Indústria Farmacêutica (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 10

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Quality of life [eleven months]

Secondary Outcome Measures

1. Quality of life in differents phases of menacme [eleven months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 46 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01174524
• Other Study ID Numbers: MedleyHGF
• First Posted: Aug 3, 2010
• Last Update Posted: Aug 3, 2010
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Quality of life; Menopause; Contraception
• Additional relevant MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Gestodene; Femovan; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate

Study Results

No Results Posted as of Aug 3, 2010