Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Quality of life [ Time Frame: eleven months ] [ Designated as safety issue: Yes ]
- 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:
Drug: ethinylestradiol 15 mcg
ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen
Other Names:
|
Eligibility| Ages Eligible for Study: | 15 Years to 46 Years |
| Genders 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| Brazil | |
| Hospital Geral de Fortaleza | |
| Fortaleza, Ceara, Brazil, 60115290 | |
| 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:
|
Contraceptive Agents Gestodene Contraceptives, Oral Estradiol Ethinyl Estradiol Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Progestins |
ClinicalTrials.gov processed this record on May 21, 2013