Polycystic Ovary SyndromePhase 3NCT00714233
Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
A Phase 3 study testing Metformin, Oral Contraceptive Pills (Yasmin) and Lifestyle Modification in people with Polycystic Ovary Syndrome, run by University of Rochester.
Trial summary
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin, Oral Contraceptive Pills (Yasmin) and Lifestyle Modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Menstrual irregularity defined as cycle length > 45 days
- Overweight as BMI > 25
- Clinical evidence of hirsuitism or acne
- Testosterone > 50ng/dL
Who cannot join
- History of diabetes mellitus
- History of Cushing's disease
- History of hyperprolactinemia
- Untreated hypo or hyperthyroidism
- History of adrenal hyperplasia
- Significant renal impairment
- Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
- Exercise > 10 hours per week
About this study
Official title: Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:
- reduce fasting glucose levels
- reduce androgen hormone levels
- improve sex steroid binding, and
- improve lipids (fatty substances in the blood)
Read the detailed description
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.
Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Oral Contraceptive Pills (Yasmin), Lifestyle Modification, placebo
- Keywords
- Polycystic Ovary Syndrome, Overweight Adolescent Girls, Irregular Menstrual Cycles
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 425mg. capsules, 2 capsules BID x 24 weeks
Oral Contraceptive Pills (Yasmin)Drug
Also called Yasmin oral COntraceptive tabs
Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks
Lifestyle ModificationBehavioural
weekly classes x 24 weeks for training in diet, exercise and behavior modification skills
placeboDrug
Also called pharmacy matched placebo capsules
placebo to the active metformin arm. 2 capsules BID x 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metformin Receives: Drug: Metformin |
| 2 | Experimental | Oral Contraceptive Pills Receives: Drug: Oral Contraceptive Pills (Yasmin) |
| 3 | Active comparator | lifestyle modification program Receives: Behavioral: Lifestyle Modification |
| 4 | Placebo comparator | placebo to active metformin arm Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
Measured: 24 week
Secondary outcomes (5)
Weight Loss in Lifestyle Intervention Group
In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI
Measured: baseline and 24 weeks
Change in Free Androgen Index (FAI)
Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.
Measured: baseline and 24 weeks
Change in SHBG
Measurement of SHBG by treatment group pre and post intervention
Measured: baseline and 24 weeks
Triglyceride Concentration by Treatment Group
Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo
Measured: baseline and 24 weeks
Change in Fasting Glucose
Change in fasting glucose concentration by treatment group pre to post intervention
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startAug 2002
- Primary completionApr 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen M. Hoeger, MD, University of Rochester
- Investigators
- Kathleen M Hoeger, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714233
- Sponsor's protocol ID
- RSRB # 09354
- Status last verified
- May 2011
- First submitted
- 8 Jul 2008
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT00714233
- Acronym / sponsor ID
- RSRB # 09354
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Overweight Adolescent Girls, Irregular Menstrual Cycles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 16 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:
- reduce fasting glucose levels
- reduce androgen hormone levels
- improve sex steroid binding, and
- improve lipids (fatty substances in the blood)
Detailed description
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.
Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MetforminMetformin |
| 2 | Experimental | Drug: Oral Contraceptive Pills (Yasmin)Oral Contraceptive Pills |
| 3 | Active comparator | Behavioral: Lifestyle Modificationlifestyle modification program |
| 4 | Placebo comparator | Drug: placeboplacebo to active metformin arm |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Menstrual irregularity defined as cycle length > 45 days
- Overweight as BMI > 25
- Clinical evidence of hirsuitism or acne
- Testosterone > 50ng/dL
Key exclusion criteria (8 listed)
- History of diabetes mellitus
- History of Cushing's disease
- History of hyperprolactinemia
- Untreated hypo or hyperthyroidism
- History of adrenal hyperplasia
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 |
|---|---|---|
| MetforminMetformin 425mg. capsules, 2 capsules BID x 24 weeks | Drug | 1 |
| Oral Contraceptive Pills (Yasmin)Also: Yasmin oral COntraceptive tabsYasmin oral contraceptive tabs; 1 tab daily x 24 weeks | Drug | 2 |
| Lifestyle Modificationweekly classes x 24 weeks for training in diet, exercise and behavior modification skills | Behavioural | 3 |
| placeboAlso: pharmacy matched placebo capsulesplacebo to the active metformin arm. 2 capsules BID x 24 weeks. | Drug | 4 |
Primary outcome
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
Time frame: 24 week
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
5 secondary outcomes
Weight Loss in Lifestyle Intervention Group
Time frame: baseline and 24 weeks
Change in Free Androgen Index (FAI)
Time frame: baseline and 24 weeks
Change in SHBG
Time frame: baseline and 24 weeks
Triglyceride Concentration by Treatment Group
Time frame: baseline and 24 weeks
Change in Fasting Glucose
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.
Kathleen M Hoeger, MD principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin, Oral Contraceptive Pills (Yasmin) and Lifestyle Modification in people with Polycystic Ovary Syndrome, run by University of Rochester.
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 4 inclusion and 8 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 15 May 2015. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification (time frame: 24 week). 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 15 May 2015.