Polycystic Ovary Syndrome17b-ACONCT01372293
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
A study testing oral contraceptive pill in people with Polycystic Ovary Syndrome, run by Federal University of Rio Grande do Sul.
Trial summary
An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- oral contraceptive pill
- Type of treatment
- Pill or oral medicine
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2010
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- hirsute women with polycystic ovary syndrome
Who cannot join
- Use of any drugs known to interfere with hormone levels for at least 3 months before the study
- Women with type 2 diabetes, homa index > 3.8, liver or renal disease or thyroid dysfunction
- Other hyperandrogenic disorders than PCOS
About this study
Official title: 17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study
An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.
Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- oral contraceptive pill
- Keywords
- PCOS, oral contraceptive pill, polymorphisms
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral contraceptive pillDrug
ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes at Ferriman- Gallwey score
Measured: 6 months
Secondary outcomes (2)
Changes at testosterone levels
Measured: 6 months
Changes in lipid profile
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Denusa Wiltgen, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372293
- Sponsor's protocol ID
- 04-245
- Acronym
- 17b-ACO
- Status last verified
- Sep 2011
- First submitted
- 10 Jun 2011
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Maier PS, Mattiello SS, Lages L, Spritzer PM. 17-Hydroxysteroid dehydrogenase type 5 gene polymorphism (-71A/G HSD17B5 SNP) and treatment with oral contraceptive pills in PCOS women without metabolic comorbidities. Gynecol Endocrinol. 2012 Aug;28(8):606-10. doi: 10.3109/09513590.2011.650760. Epub 2012 Feb 14.
PubMed 22329763
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT01372293
- Acronym / sponsor ID
- 17b-ACO / 04-245
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, oral contraceptive pill, polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jun 2011 (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.
An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.
Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- hirsute women with polycystic ovary syndrome
Key exclusion criteria (3 listed)
- Use of any drugs known to interfere with hormone levels for at least 3 months before the study
- Women with type 2 diabetes, homa index > 3.8, liver or renal disease or thyroid dysfunction
- Other hyperandrogenic disorders than PCOS
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 |
|---|---|---|
| oral contraceptive pillethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles | Drug | – |
Primary outcome
Changes at Ferriman- Gallwey score
Time frame: 6 months
2 secondary outcomes
Changes at testosterone levels
Time frame: 6 months
Changes in lipid profile
Time frame: 6 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 12 Sep 2011.
- Derived from this study: PubMed 22329763Maier PS, Mattiello SS, Lages L, Spritzer PM. 17-Hydroxysteroid dehydrogenase type 5 gene polymorphism (-71A/G HSD17B5 SNP) and treatment with oral contraceptive pills in PCOS women without metabolic comorbidities. Gynecol Endocrinol. 2012 Aug;28(8):606-10. doi: 10.3109/09513590.2011.650760. Epub 2012 Feb 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing oral contraceptive pill in people with Polycystic Ovary Syndrome, run by Federal University of Rio Grande do Sul.
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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Changes at Ferriman- Gallwey score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372293, which also lists 1 linked publication.
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 12 Sep 2011.