Polycystic Ovary SyndromePhase 3NCT00283816
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
A Phase 3 study testing Metformin, Oral Contraceptive Pill and Lifestyle Management Program in people with Polycystic Ovary Syndrome, run by University of Rochester at 1 site in United States.
Trial summary
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. 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 Pill and Lifestyle Management Program
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2008
- 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
Inclusion Criteria:Age 12-18 years; Menstrual irregularity; Overweight; Must be able to swallow capsules; At lease 6 months since onset of first menstrual cycle.
Exclusion Criteria:Diabetes; Kidney or Liver disease; Tobacco use; Depression or Bipolar Disease; Contraindication to exercise; Weight > 300 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.
Read the detailed description
Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS.
The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Oral Contraceptive Pill, Lifestyle Management Program, Quality of Life Questionnaire, Oral Glucose Tolerance Test
- 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
Also called Metformin Hydrochloride Tablets, 500 mg., manufacturer: Mylan Pharmaceuticals, Morgantown, WV
Metformin 500 mg. tabs 2 tabs BID for duration of study
Oral Contraceptive PillDrug
Also called Yasmin 28 tablets, Manufacturer: Berlex, Montville, NJ 07045
Yasmin, drospirenone and ethinyl estradiol 28 tablets
1 tab daily for duration of study
Lifestyle Management ProgramBehavioural
Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise \& behavior modification skills on a regular weekly basis over the 24 week study
Quality of Life QuestionnaireBehavioural
Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion
Oral Glucose Tolerance TestProcedure or surgery
Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance.
Performed twice during study, at baseline and conclusion
Blood workProcedure or surgery
Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids.
Abdominal Ultra SoundProcedure or surgery
transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume.
Performed twice during study, at baseline and conclusion
Dual-energy x-ray absorptiometry (DEXA scan)Procedure or surgery
Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion
placeboDrug
Also called placebo formulation: 240 mg. lactose powder USP, in size 3 capsules from Capsugel
placebo capsules, two capsules BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | metformin Receives: Drug: Metformin; Drug: Oral Contraceptive Pill; Behavioral: Lifestyle Management Program; Behavioral: Quality of Life Questionnaire; Procedure: Oral Glucose Tolerance Test; Procedure: Blood work; Procedure: Abdominal Ultra Sound; Procedure: Dual-energy x-ray absorptiometry (DEXA scan) |
| 0 | Placebo comparator | placebo Receives: Drug: Oral Contraceptive Pill; Behavioral: Lifestyle Management Program; Behavioral: Quality of Life Questionnaire; Procedure: Oral Glucose Tolerance Test; Procedure: Blood work; Procedure: Abdominal Ultra Sound; Procedure: Dual-energy x-ray absorptiometry (DEXA scan); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Abdominal Fat as Measured by Waist Circumference.
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
Measured: baseline and 24 weeks
Secondary outcomes (3)
Change in Weight Post Minus Pre Intervention.
Body mass index change in adolescents enrolled in lifestyle intervention program
Measured: baseline and 24 weeks
Total Testosterone Change
Change in total testosterone post minus pre intervention
Measured: baseline and 24 weeks
Change in Sex Hormone Binding Globulin (SHBG)
SHBG concentration post minus pre-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 posted30 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2008
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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 Hoeger, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283816
- Sponsor's protocol ID
- RSRB-00012501
- Other IDs
- GCRC#1083
- Status last verified
- Apr 2011
- First submitted
- 27 Jan 2006
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- Metabolic Impact of Oral Contraceptives With or Without Metformin in Obese Adolescents With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT00283816
- Acronym / sponsor ID
- RSRB-00012501
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Overweight Adolescent Girls, Irregular Menstrual Cycles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Jan 2006 (estimated)
- Results
- Posted 13 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metabolic state.The study will also test a lifestyle improvement program to reduce weight.
Detailed description
Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS.
The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Metformin, Drug: Oral Contraceptive Pill, Behavioral: Lifestyle Management Program, Behavioral: Quality of Life Questionnaire, Procedure: Oral Glucose Tolerance Test, Procedure: Blood work, Procedure: Abdominal Ultra Sound, Procedure: Dual-energy x-ray absorptiometry (DEXA scan)metformin |
| 0 | Placebo comparator | Drug: Oral Contraceptive Pill, Behavioral: Lifestyle Management Program, Behavioral: Quality of Life Questionnaire, Procedure: Oral Glucose Tolerance Test, Procedure: Blood work, Procedure: Abdominal Ultra Sound, Procedure: Dual-energy x-ray absorptiometry (DEXA scan), Drug: placeboplacebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| MetforminAlso: Metformin Hydrochloride Tablets, 500 mg., manufacturer: Mylan Pharmaceuticals, Morgantown, WVMetformin 500 mg. tabs 2 tabs BID for duration of study | Drug | 1 |
| Oral Contraceptive PillAlso: Yasmin 28 tablets, Manufacturer: Berlex, Montville, NJ 07045Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study | Drug | 0, 1 |
| Lifestyle Management ProgramSubjects and a parent/guardian will participate in a series of classes for training in diet, exercise \& behavior modification skills on a regular weekly basis over the 24 week study | Behavioural | 0, 1 |
| Quality of Life QuestionnaireQuality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion | Behavioural | 0, 1 |
| Oral Glucose Tolerance TestInsulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion | Procedure or surgery | 0, 1 |
| Blood workInitial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids. | Procedure or surgery | 0, 1 |
| Abdominal Ultra Soundtransabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion | Procedure or surgery | 0, 1 |
| Dual-energy x-ray absorptiometry (DEXA scan)Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion | Procedure or surgery | 0, 1 |
| placeboAlso: placebo formulation: 240 mg. lactose powder USP, in size 3 capsules from Capsugelplacebo capsules, two capsules BID | Drug | 0 |
Primary outcome
Reduction in Abdominal Fat as Measured by Waist Circumference.
Time frame: baseline and 24 weeks
Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention
3 secondary outcomes
Change in Weight Post Minus Pre Intervention.
Time frame: baseline and 24 weeks
Total Testosterone Change
Time frame: baseline and 24 weeks
Change in Sex Hormone Binding Globulin (SHBG)
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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PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
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
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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 Hoeger, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin, Oral Contraceptive Pill and Lifestyle Management Program in people with Polycystic Ovary Syndrome, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 13 Jul 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?
Reduction in Abdominal Fat as Measured by Waist Circumference. (time frame: baseline and 24 weeks). 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.