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

NCT01174524 | Completed Phase 4

• 1 other identifier: MedleyHGF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Menopause; Contraception

Keywords

Quality of life; Menopause; Contraception

Outcome Measures

Primary Outcomes (1)

• Quality of life

  eleven months

Secondary Outcomes (1)

• Quality of life in differents phases of menacme

  eleven months

Study Arms (1)

gestoden and ethinylestradiol

EXPERIMENTAL

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; Drug: ethinylestradiol 15 mcg

Interventions

gestoden 60 mcg DRUG

gestoden 60 mcg, once a day, administered in 24/4 regimen.

Also known as: oral contraceptives, quality of life, gestodene and ethinyl estradiol

gestoden and ethinylestradiol

ethinylestradiol 15 mcg DRUG

ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen

Also known as: gestodene and ethinyl estradiol, quality of life, oral contraceptives

gestoden and ethinylestradiol

Eligibility Criteria

• Age: 15 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fertile women with indication of use of contraceptive pills

You may not qualify if:

• Fertile women with any surgical contraceptive method
• Women in menopause
• Diseases the forbidden the use of the drug

Sponsors & Collaborators

• Hospital Geral de Fortaleza: lead
• Medley S∕A Indústria Farmacêutica: collaborator

Study Sites (1)

Hospital Geral de Fortaleza

Fortaleza, Ceará, 60115290, Brazil

Location

MeSH Terms

Interventions

Gestodene; Contraceptives, Oral; Quality of Life; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• joao MM Silva, PhD Student

  Hospital Geral de Fortaleza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: August 3, 2010
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 3, 2010

Record last verified: 2009-01

Locations

BR (1)