Polycystic Ovary SyndromeNCT00005104
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
A study testing clomiphene citrate and metformin in people with Polycystic Ovary Syndrome and Hyperinsulinism, run by National Center for Research Resources (NCRR) at 6 sites in 2 countries.
Trial summary
OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Hyperinsulinism
- What is being tested?
- clomiphene citrate and metformin
- How many people
- 99 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2000to not given
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate
Must have oligoovulation and hyperandrogenemia
--Prior/Concurrent Therapy--
Endocrine therapy: At least 2 months since prior clomiphene citrate
Other:
- At least 2 months since prior standard therapy (including over the counter drugs)
- At least 2 months since prior investigational drugs
- Prior multi/prenatal vitamins allowed
--Patient Characteristics--
Hematopoietic: Hematocrit greater than 38%
Hepatic:
- Liver function normal
- No clinically significant hepatic disease
Renal:
- No clinically significant renal disease
- Creatinine less than 1.4 mg/dL
- No proteinuria
Cardiovascular: No clinically significant cardiac disease
Pulmonary: No clinically significant pulmonary disease
Hormonal:
- Thyroid function normal
- Prolactin normal
- Estradiol normal
- Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency
Other:
- Not pregnant
- Negative pregnancy test
- Male partner must have a normal semen analysis by WHO criteria
- Must be in acceptable health by interview, medical history, physical exam, and laboratory tests
- No diabetes mellitus
- No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease
- No clinically significant malignant disease except nonmelanomatous skin cancer
- At least 1 year since any prior drug abuse or alcoholism
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
University of Virginia
Charlottesville, Virginia, 22908
Medical College of Virginia School of Medicine
Richmond, Virginia, 23298-0230
Louisiana State University School of Medicine
Shreveport, Louisiana, 71130-3932
Washington University - St. Louis
St Louis, Missouri, 63110
About this study
OBJECTIVES:
- Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.
Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.
- Conditions
- Polycystic Ovary Syndrome, Hyperinsulinism
- Being tested
- clomiphene citrate, metformin
- Keywords
- endocrine disorders, hyperinsulinism, polycystic ovarian syndrome, rare disease
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperinsulinism, Endocrine System Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clomiphene citrateDrug
metforminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2000 (estimated)
- Study startJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Masking
- Double blind
- Enrolment
- 99 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Virginia
- Investigators
- William S. Evans, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005104
- Sponsor's protocol ID
- 199/14915
- Other IDs
- UVA-HIC-7538, UVA-WSE026
- Status last verified
- Dec 2003
- First submitted
- 6 Apr 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00005104
- Acronym / sponsor ID
- 199/14915
- Conditions
- Polycystic Ovary Syndrome, Hyperinsulinism
- Keywords
- endocrine disorders, hyperinsulinism, polycystic ovarian syndrome, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- University of Virginia
- Study start
- Jan 2000
- First posted
- 7 Apr 2000 (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.
OBJECTIVES:
- Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.
Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| clomiphene citrate | Drug | – |
| metformin | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
William S. Evans study chair
University of Virginia
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clomiphene citrate and metformin in people with Polycystic Ovary Syndrome and Hyperinsulinism, run by National Center for Research Resources (NCRR) at 6 sites in 2 countries.
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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy. 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.
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.
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 24 Jun 2005.