Quality of LifePhase 4NCT01174524
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
A Phase 4 study testing gestoden 60 mcg and ethinylestradiol 15 mcg in people with Quality of Life and Menopause, run by Hospital Geral de Fortaleza at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Menopause, Contraception
- What is being tested?
- gestoden 60 mcg and ethinylestradiol 15 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 46 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fertile women with indication of use of contraceptive pills
Who cannot join
- Fertile women with any surgical contraceptive method
- Women in menopause
- Diseases the forbidden the use of the drug
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- gestoden 60 mcg, ethinylestradiol 15 mcg
- Keywords
- Quality of life, Menopause, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gestoden 60 mcgDrug
Also called oral contraceptives, quality of life, gestodene and ethinyl estradiol
gestoden 60 mcg, once a day, administered in 24/4 regimen.
ethinylestradiol 15 mcgDrug
Also called gestodene and ethinyl estradiol, quality of life, oral contraceptives
ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: gestoden 60 mcg; Drug: ethinylestradiol 15 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: eleven months
Secondary outcomes (1)
Quality of life in differents phases of menacme
Measured: eleven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Geral de Fortaleza
- Sponsor type
- Other government
- Collaborators
- Medley S∕A Indústria Farmacêutica
- Investigators
- joao MM Silva, PhD Student, Principal investigator, Hospital Geral de Fortaleza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174524
- Sponsor's protocol ID
- MedleyHGF
- Status last verified
- Jan 2009
- First submitted
- 29 Dec 2008
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
- ClinicalTrials.gov ID
- NCT01174524
- Acronym / sponsor ID
- MedleyHGF
- Conditions
- Quality of Life, Menopause, Contraception
- Keywords
- Quality of life, Menopause, Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Geral de FortalezaOther government
- Collaborators
- Medley S∕A Indústria Farmacêutica
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gestoden and ethinylestradiol | Experimental | Drug: gestoden 60 mcg, Drug: ethinylestradiol 15 mcgGestoden 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. |
Who may qualify
- Ages
- 15 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Fertile women with indication of use of contraceptive pills
Key exclusion criteria (3 listed)
- Fertile women with any surgical contraceptive method
- Women in menopause
- Diseases the forbidden the use of the drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gestoden 60 mcgAlso: oral contraceptives, quality of life, gestodene and ethinyl estradiolgestoden 60 mcg, once a day, administered in 24/4 regimen. | Drug | gestoden and ethinylestradiol |
| ethinylestradiol 15 mcgAlso: gestodene and ethinyl estradiol, quality of life, oral contraceptivesethinylestradiol 15 mcg, once a day, administered in 24/4 regimen | Drug | gestoden and ethinylestradiol |
Primary outcome
Quality of life
Time frame: eleven months
1 secondary outcome
Quality of life in differents phases of menacme
Time frame: eleven months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
joao MM Silva, PhD Student principal investigator
Hospital Geral de Fortaleza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gestoden 60 mcg and ethinylestradiol 15 mcg in people with Quality of Life and Menopause, run by Hospital Geral de Fortaleza at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: eleven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2010; AzTrials last refreshed its copy on 7 Nov 2026.