AmenorrheaPhase 4NCT01103518
Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
A Phase 4 study testing Ethinyl Estradiol + Cyproterone acetate in people with Amenorrhea and Dysmenorrhea, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
Trial summary
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Amenorrhea, Dysmenorrhea, Menstruation Disturbances
- What is being tested?
- Ethinyl Estradiol + Cyproterone acetate
- 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
- Dec 2009to Jan 2011
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subject
- Premenopausal subject
- 18 years or older
- Medical history of irregular menses lasting at least 3 months
- Signature of informed consent
Who cannot join
- Pregnancy
- Use of hormonal contraceptives within 3 months of screening
- Primary bilateral oophorectomy
- Chemotherapy and / or radiotherapy within 6 months of screening
- Hysterectomy
- Myotonic dystrophy
Show all 13Show fewer
- Galactosemia
- Galactorrhea
- History of tuberculosis or schistosomiasis
- Elevated prolactin / other significant laboratory alterations
- Diabetes
- Premature ovarian deficiency
- Sensitivity to any component of the drug formula
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas de Teresópolis
Teresópolis, Rio de Janeiro, 25976-016
About this study
Official title: Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
- Conditions
- Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism
- Being tested
- Ethinyl Estradiol + Cyproterone acetate
- Keywords
- Menstrual irregularity, Menstruation disturbances, Hyperandrogenism
- Medical subject headings
- Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol + Cyproterone acetateDrug
Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Combination 1 | Experimental | Ethinyl Estradiol + Cyproterone acetate Receives: Drug: Ethinyl Estradiol + Cyproterone acetate |
| Combination 2 | Active comparator | Ethinyl Estradiol + Cyproterone acetate Receives: Drug: Ethinyl Estradiol + Cyproterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regular Menstruation
Percentage of subjects with regular menstruation at the end of treatment month 3
Measured: Treatment month 3
Secondary outcomes (9)
Menstrual flow
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3
Measured: Treatment months 3
Menstrual colic
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.
Measured: Treatment month 3
Global self evaluation scores
Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.
Measured: Treatment month 6
Willingness to continue treatment
Percentage of subjects willing to continue treatment with study drug
Measured: Treatment month 6
Safety
Incidence, duration and severity of adverse events, including laboratory tests.
Measured: Treatment and follow-up period
Menstrual Flow
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4
Measured: Treatment month 4
Menstrual Flow
Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.
Measured: Treatment month 5
Menstrual Colic
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.
Measured: Treatment month 4
Menstrual Colic
Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.
Measured: Treatment month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionNov 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Investigators
- Carlos RB Gama, M.D., Principal investigator, Fundação Educacional Serra dos ÓrgãosCarlos P Nunes, M.D., Study director, Fundação Educacional Serra dos Órgãos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103518
- Sponsor's protocol ID
- AMI 1-16-08-09
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
- ClinicalTrials.gov ID
- NCT01103518
- Acronym / sponsor ID
- AMI 1-16-08-09
- Conditions
- Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism
- Keywords
- Menstrual irregularity, Menstruation disturbances, Hyperandrogenism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 14 Apr 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.
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination 1 | Experimental | Drug: Ethinyl Estradiol + Cyproterone acetateEthinyl Estradiol + Cyproterone acetate |
| Combination 2 | Active comparator | Drug: Ethinyl Estradiol + Cyproterone acetateEthinyl Estradiol + Cyproterone acetate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subject
- Premenopausal subject
- 18 years or older
- Medical history of irregular menses lasting at least 3 months
- Signature of informed consent
Key exclusion criteria (13 listed)
- Pregnancy
- Use of hormonal contraceptives within 3 months of screening
- Primary bilateral oophorectomy
- Chemotherapy and / or radiotherapy within 6 months of screening
- Hysterectomy
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 |
|---|---|---|
| Ethinyl Estradiol + Cyproterone acetateEthinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period. | Drug | Combination 1, Combination 2 |
Primary outcome
Regular Menstruation
Time frame: Treatment month 3
Percentage of subjects with regular menstruation at the end of treatment month 3
9 secondary outcomes
Menstrual flow
Time frame: Treatment months 3
Menstrual colic
Time frame: Treatment month 3
Global self evaluation scores
Time frame: Treatment month 6
Willingness to continue treatment
Time frame: Treatment month 6
Safety
Time frame: Treatment and follow-up period
Menstrual Flow
Time frame: Treatment month 4
Menstrual Flow
Time frame: Treatment month 5
Menstrual Colic
Time frame: Treatment month 4
Menstrual Colic
Time frame: Treatment month 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Carlos RB Gama, M.D. principal investigator
Fundação Educacional Serra dos Órgãos
Carlos P Nunes, M.D. study director
Fundação Educacional Serra dos Órgãos
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 Ethinyl Estradiol + Cyproterone acetate in people with Amenorrhea and Dysmenorrhea, run by Fundação Educacional Serra dos Órgãos 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 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?
Results are not available in the source record.
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?
Regular Menstruation (time frame: Treatment month 3). 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 6 Aug 2010.