Polycystic Ovary SyndromeEarly Phase 1SHK002NCT03905941
Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age
A Early Phase 1 study testing Metformin and Oral combined hormonal contraceptives in people with Polycystic Ovary Syndrome, run by University of Virginia at 1 site in United States.
Trial summary
The goal of this study is to determine the relative desirability of metformin vs. oral combined hormonal contraceptives (OCs) in treating Polycystic Ovary Syndrome (PCOS) in women of later reproductive age. Polycystic Ovary Syndrome Questionnaire (PCOSQ) score will be used as a proxy for patient satisfaction. Read more about this study
- Who is it for?
- Ages 40 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and Oral combined hormonal contraceptives
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 25 Nov 2024
- Phase
- Early Phase 1
- 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 40 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with PCOS aged 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea or irregular menstruation (substantially inconsistent menstrual cycle length). Subjects with fewer than 10 menses/year or average menstrual cycle length >35 days are allowed to participate if they have a compelling past history of oligomenorrhea (average menstrual cycle length >45 days or fewer than 9 menses/year) or irregular menstruation.
- Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for exclusion (see exclusion criteria).
- Subjects must be willing and able to provide written informed consent.
- Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study
- Willingness and ability to comply with scheduled visits and study procedures
Who cannot join
- Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone [FSH] level)
- Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL. As an alternative, cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH >9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3
- History of hysterectomy and/or bilateral oophorectomy
- BMI ≥ 40 kg/m2
- Inability to comprehend what will be done during the study or why it will be done.
- Being a study of older women with PCOS, children and men will be excluded.
Show all 37Show fewer
- Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician.
- Prisoners.
- History of (or clinical evidence for) Cushing's syndrome or adrenal insufficiency.
- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone (17-OHP) >200 ng/dL, which suggest the possibility of congenital adrenal hyperplasia. 17-OHP will be collected during follicular phase. NOTE: if a 17-OHP >200 ng/dL and is confirmed on repeat testing, an ACTH-stimulated 17-OHP <1000 ng/dL will be required for study participation.
- Total testosterone >150 ng/dL, which suggests the possibility of virilizing neoplasm.
- DHEA-S greater than 1.5 times the upper limit of normal range (mild elevations may be seen in PCOS, so elevations < 1.5 times the upper limit of normal will be accepted in these groups).
- Virilization
- Diagnosis of diabetes mellitus (DM), fasting glucose ≥ 126 mg/dL, or a hemoglobin A1c of ≥ 6.5%.
- Abnormal thyroid stimulating hormone (TSH). Subjects with stable and adequately-treated hypothyroidism, reflected by normal TSH values, will not be excluded.
- Moderate to severe hyperprolactinemia. Mild prolactin elevations may be seen in PCOS, and elevations < 1.5 times the upper limit of normal will be accepted in this group.
- Persistent liver abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild transaminase elevations may be seen in women with obesity, so elevations <1.5 times the upper limit of normal will be accepted in this group.
- Persistent hematocrit <36% and hemoglobin <12 g/dL.
- Abnormal sodium, potassium, or bicarbonate concentrations or elevated creatinine concentration.
- Significant history of pulmonary dysfunction (e.g., asthma or COPD requiring intermittent systemic corticosteroid, pulmonary hypertension, etc.).
- History of known or suspected congestive heart failure.
- History of known or suspected ischemic heart disease or cerebrovascular disease.
- History of hypertension.
- History of uncontrolled/untreated dyslipidemia. Subjects with stable and adequately treated dyslipidemia reflected by normal lipid panel values will not be excluded.
- History of complicated valvular heart disease (e.g. pulmonary hypertension, risk of atrial fibrillation, history of subacute bacterial endocarditis)
- History of stroke
- History of smoking
- History of severe cirrhosis or liver tumor (e.g. hepatocellular adenoma or malignant hepatoma).
- Use of anticonvulsants, rifampicin or rifabutin therapy. The interaction of these drugs with OCs will not be harmful to the subjects, but it will reduce the effectiveness of OCs.
- History of venous thromboembolism (e.g. deep venous thrombosis (DVT), pulmonary embolism (PE)).
- Personal history of blood clotting disorders (e.g., protein C, protein S, positive antiphospholipid antibodies).
- First-degree relative history of blood clotting disorder, unless the same disorder has been formally excluded for the study subject.
- History of migraine headaches.
- History of breast, ovarian, or endometrial cancer.
- Note: If endometrial thickness on transvaginal ultrasound is >8 mm in the proliferative (follicular) phase or >14 mm in the secretory (luteal) phase, the subject will be referred to a gynecologist for further evaluation (38). These particular subjects will be required to obtain a clearance from their gynecologist to participate in this study.
- Note: Any abnormal labs may be repeated to exclude a lab error.
- No medications known to affect the reproductive system can be taken in the 2 months prior to screening and in the 3 months prior to the study. Such medications include oral contraceptive pills, metformin, progestins, glucocorticoids, anti-psychotics, and/or mood stabilizers that are known to cause hormone abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22901
About this study
The goal of this study is to determine the relative desirability of metformin vs. oral combined hormonal contraceptives (OCs) in treating Polycystic Ovary Syndrome (PCOS) in women of later reproductive age. Polycystic Ovary Syndrome Questionnaire (PCOSQ) score will be used as a proxy for patient satisfaction. In light of their respective effects on the classic and metabolic facets of PCOS, metformin will provide non-inferior patient satisfaction compared to OCs in later reproductive age women with PCOS.
Read the detailed description
This is a randomized, controlled, double-blinded, crossover study. The investigators will recruit women with PCOS in ages 40-49 yo. Subjects will be randomized to either receive metformin (2000 mg daily) or low dose oral contraceptives (OCs: 20 mcg ethinyl estradiol/norethindrone acetate 1mg) for a total of 6 months, and they will crossover to the other treatment for the following 6 months. Subjects will have the following assessed at baseline and 6 months after each study medication: blood pressure, weight, waist-to-hip ratio (WHR), average intermenstrual cycle length (in the previous 3 months), Ferriman-Gallwey score (as a measure of hirsutism), total testosterone (T), sex hormone binding globulin, calculated free T, fasting insulin, fasting glucose, 2-h glucose (during oral glucose tolerance test), Matsuda index, HgA1c, LDL-cholesterol, HDL-cholesterol, triglycerides, estimated cardiovascular risk (Framingham risk score), health-related quality of life using both PCOS questionnaire (PCOSQ) and the Short-Form Health Survey (SF-36), and severity of anxiety using Generalized Anxiety Disorder-7 (GAD-7) questionnaire. For safety surveillance, the investigators will measure electrolyte levels, renal function, liver function, and pregnancy tests immediately before study mediation initiation and every 3 months. For statistical analysis, per PCOSQ domain, the post-treatment QoL scores will be analyzed via a linear mixed model (LMM), in which the LMM will be specified in accordance with a 2 treatment by 2 period crossover design. The investigators determined that if 73 subjects complete the study, the investigators expect to have at least an 80% chance of rejecting the null hypothesis that QoL is inferior with metformin therapy vs. OCs.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Oral combined hormonal contraceptives
- Keywords
- Polycystic Ovary Syndrome
- 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.
MetforminDrug
Metformin 2000 mg/day will be used in this study. Metformin is a antihyperglycemic agent that is used as a first line medical therapy to treat type 2 diabetes mellitus. It is also used to prevent progression of impaired glucose tolerance. It decrease hepatic glucose production and increase insulin sensitivity.
Oral combined hormonal contraceptivesDrug
Oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg will be used in this study. OCs are normally used to prevent pregnancy by suppressing ovulation and to prevent endometrial hyperplasia by inducing regular "withdrawal" bleeding. OCs help control both clinical and biochemical hyperandrogenism in PCOS and are considered first line medical therapy until the age of menopause.
| Study group | Role | What they receive |
|---|---|---|
| Metformin then oral combined hormonal contraceptives | Experimental | Subjects will take metformin 2000 mg/day for the first 6 months, followed by 6 months of oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg. Receives: Drug: Metformin; Drug: Oral combined hormonal contraceptives |
| Oral combined hormonal contraceptives then metformin | Active comparator | Subjects will take oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg for the first 6 months, followed by 6 months of metformin 2000 mg/day. Receives: Drug: Metformin; Drug: Oral combined hormonal contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score
It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Measured: baseline
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score
It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Measured: 6 months after each intervention.
Secondary outcomes (36)
Short Form (SF)-36 score
It consists of 36 items and has eight scaled scores (transformed into 0-100 scale). It assesses health related quality of life (general). The increasing score indicates better health status.
Measured: baseline
Short Form (SF)-36 score
It consists of 36 items and has eight scaled scores (transformed into 0-100 scale). It assesses health related quality of life (general). The increasing score indicates better health status.
Measured: 6 months after each intervention
General Anxiety Disorder (GAD)-7 score
It consists of 7 items with a scale of 0-3, and they are summed up to a total score. Increasing scores mean a greater functional impairment.
Measured: baseline
General Anxiety Disorder (GAD)-7 score
It consists of 7 items with a scale of 0-3, and they are summed up to a total score. Increasing scores mean a greater functional impairment.
Measured: 6 months after each intervention
Total testosterone concentrations
ng/dL
Measured: baseline
Total testosterone concentrations
ng/dL
Measured: 6 months after each intervention
Calculated free testosterone concentrations
pg/mL
Measured: baseline
Calculated free testosterone concentrations
pg/mL
Measured: 6 months after each intervention
Sex hormone binding globulin
nmoL/L
Measured: baseline
Sex hormone binding globulin
nmoL/L
Measured: 6 months after each intervention
LDL cholesterol level
mg/dL
Measured: baseline
LDL cholesterol level
mg/dL
Measured: 6 months after each intervention
HDL cholesterol level
mg/dL
Measured: baseline
HDL cholesterol level
mg/dL
Measured: 6 months after each intervention
Triglyceride level
mg/dL
Measured: baseline
Triglyceride level
mg/dL
Measured: 6 months after each intervention
Blood pressure
mmHg
Measured: baseline
Blood pressure
mmHg
Measured: 6 months after each intervention
Weight
kg
Measured: baseline
Weight
kg
Measured: 6 months after each intervention
Body mass index
kg/meter square
Measured: baseline
Body mass index
kg/meter square
Measured: 6 months after each intervention
waist-to-hip ratio
It is a ratio of waist and hip circumference
Measured: baseline
waist-to-hip ratio
It is a ratio of waist and hip circumference
Measured: 6 months after each intervention
Matsuda index
It is an index to assess insulin sensitivity.
Measured: baseline
Matsuda index
It is an index to assess insulin sensitivity.
Measured: 6 months after each intervention
Fasting insulin
uIU/mL
Measured: baseline
Fasting insulin
uIU/mL
Measured: 6 months after each intervention
Fasting glucose
mg/dL
Measured: baseline
Fasting glucose
mg/dL
Measured: 6 months after each intervention
2-hour glucose level during oral glucose tolerance test
mg/dL
Measured: baseline
2-hour glucose level during oral glucose tolerance test
mg/dL
Measured: 6 months after each intervention
Hemoglobin A1c
percent
Measured: baseline
Hemoglobin A1c
percent
Measured: 6 months after each intervention
Framingham risk score
This is a risk assessing measure that estimates the 10 year cardiovascular risk for an individual. There is no scale for this. A total risk (in percentage) will be calculated.
Measured: baseline
Framingham risk score
This is a risk assessing measure that estimates the 10 year cardiovascular risk for an individual. There is no scale for this. A total risk (in percentage) will be calculated.
Measured: 6 months after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start23 Aug 2021
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Why it stopped: No funding, time, or personnel to complete this study.
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.
- More trials run by University of VirginiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, controlled, double blinded, controlled, crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Burt Solorzano, University of Virginia
- Investigators
- Christine Burt Solorzano, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905941
- Sponsor's protocol ID
- 21649
- Acronym
- SHK002
- Status last verified
- Feb 2026
- First submitted
- 2 Apr 2019
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age
- ClinicalTrials.gov ID
- NCT03905941
- Acronym / sponsor ID
- SHK002 / 21649
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding, time, or personnel to complete this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 8 Apr 2019 (actual)
- 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.
The goal of this study is to determine the relative desirability of metformin vs. oral combined hormonal contraceptives (OCs) in treating Polycystic Ovary Syndrome (PCOS) in women of later reproductive age. Polycystic Ovary Syndrome Questionnaire (PCOSQ) score will be used as a proxy for patient satisfaction. In light of their respective effects on the classic and metabolic facets of PCOS, metformin will provide non-inferior patient satisfaction compared to OCs in later reproductive age women with PCOS.
Detailed description
This is a randomized, controlled, double-blinded, crossover study. The investigators will recruit women with PCOS in ages 40-49 yo. Subjects will be randomized to either receive metformin (2000 mg daily) or low dose oral contraceptives (OCs: 20 mcg ethinyl estradiol/norethindrone acetate 1mg) for a total of 6 months, and they will crossover to the other treatment for the following 6 months. Subjects will have the following assessed at baseline and 6 months after each study medication: blood pressure, weight, waist-to-hip ratio (WHR), average intermenstrual cycle length (in the previous 3 months), Ferriman-Gallwey score (as a measure of hirsutism), total testosterone (T), sex hormone binding globulin, calculated free T, fasting insulin, fasting glucose, 2-h glucose (during oral glucose tolerance test), Matsuda index, HgA1c, LDL-cholesterol, HDL-cholesterol, triglycerides, estimated cardiovascular risk (Framingham risk score), health-related quality of life using both PCOS questionnaire (PCOSQ) and the Short-Form Health Survey (SF-36), and severity of anxiety using Generalized Anxiety Disorder-7 (GAD-7) questionnaire. For safety surveillance, the investigators will measure electrolyte levels, renal function, liver function, and pregnancy tests immediately before study mediation initiation and every 3 months. For statistical analysis, per PCOSQ domain, the post-treatment QoL scores will be analyzed via a linear mixed model (LMM), in which the LMM will be specified in accordance with a 2 treatment by 2 period crossover design. The investigators determined that if 73 subjects complete the study, the investigators expect to have at least an 80% chance of rejecting the null hypothesis that QoL is inferior with metformin therapy vs. OCs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, double blinded, controlled, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Metformin then oral combined hormonal contraceptives | Experimental | Drug: Metformin, Drug: Oral combined hormonal contraceptivesSubjects will take metformin 2000 mg/day for the first 6 months, followed by 6 months of oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg. |
| Oral combined hormonal contraceptives then metformin | Active comparator | Drug: Metformin, Drug: Oral combined hormonal contraceptivesSubjects will take oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg for the first 6 months, followed by 6 months of metformin 2000 mg/day. |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with PCOS aged 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea or irregular menstruation (substantially inconsistent menstrual cycle length). Subjects with fewer than 10 menses/year or average menstrual cycle length >35 days are allowed to participate if they have a compelling past history of oligomenorrhea (average menstrual cycle length >45 days or fewer than 9 menses/year) or irregular menstruation.
- Screening safety labs within normal reference ranges although mild abnormalities that are common in obesity and/or hyperandrogenism will not be grounds for exclusion (see exclusion criteria).
- Subjects must be willing and able to provide written informed consent.
- Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study
- Willingness and ability to comply with scheduled visits and study procedures
Key exclusion criteria (37 listed)
- Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone [FSH] level)
- Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone <0.5 ng/mL. As an alternative, cycle day 3 FSH > 9 IU/L (with concomitant estradiol level >80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH >9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3
- History of hysterectomy and/or bilateral oophorectomy
- BMI ≥ 40 kg/m2
- Inability to comprehend what will be done during the study or why it will be done.
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 2000 mg/day will be used in this study. Metformin is a antihyperglycemic agent that is used as a first line medical therapy to treat type 2 diabetes mellitus. It is also used to prevent progression of impaired glucose tolerance. It decrease hepatic glucose production and increase insulin sensitivity. | Drug | Metformin then oral combined hormonal contraceptives, Oral combined hormonal contraceptives then metformin |
| Oral combined hormonal contraceptivesOral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg will be used in this study. OCs are normally used to prevent pregnancy by suppressing ovulation and to prevent endometrial hyperplasia by inducing regular "withdrawal" bleeding. OCs help control both clinical and biochemical hyperandrogenism in PCOS and are considered first line medical therapy until the age of menopause. | Drug | Metformin then oral combined hormonal contraceptives, Oral combined hormonal contraceptives then metformin |
Primary outcome
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score
Time frame: baseline
It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score
Time frame: 6 months after each intervention.
It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.
36 secondary outcomes
Short Form (SF)-36 score
Time frame: baseline
Short Form (SF)-36 score
Time frame: 6 months after each intervention
General Anxiety Disorder (GAD)-7 score
Time frame: baseline
General Anxiety Disorder (GAD)-7 score
Time frame: 6 months after each intervention
Total testosterone concentrations
Time frame: baseline
Total testosterone concentrations
Time frame: 6 months after each intervention
Calculated free testosterone concentrations
Time frame: baseline
Calculated free testosterone concentrations
Time frame: 6 months after each intervention
Sex hormone binding globulin
Time frame: baseline
Sex hormone binding globulin
Time frame: 6 months after each intervention
LDL cholesterol level
Time frame: baseline
LDL cholesterol level
Time frame: 6 months after each intervention
HDL cholesterol level
Time frame: baseline
HDL cholesterol level
Time frame: 6 months after each intervention
Triglyceride level
Time frame: baseline
Triglyceride level
Time frame: 6 months after each intervention
Blood pressure
Time frame: baseline
Blood pressure
Time frame: 6 months after each intervention
Weight
Time frame: baseline
Weight
Time frame: 6 months after each intervention
Body mass index
Time frame: baseline
Body mass index
Time frame: 6 months after each intervention
waist-to-hip ratio
Time frame: baseline
waist-to-hip ratio
Time frame: 6 months after each intervention
Matsuda index
Time frame: baseline
Matsuda index
Time frame: 6 months after each intervention
Fasting insulin
Time frame: baseline
Fasting insulin
Time frame: 6 months after each intervention
Fasting glucose
Time frame: baseline
Fasting glucose
Time frame: 6 months after each intervention
2-hour glucose level during oral glucose tolerance test
Time frame: baseline
2-hour glucose level during oral glucose tolerance test
Time frame: 6 months after each intervention
Hemoglobin A1c
Time frame: baseline
Hemoglobin A1c
Time frame: 6 months after each intervention
Framingham risk score
Time frame: baseline
Framingham risk score
Time frame: 6 months after each intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
Christine Burt Solorzano, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin and Oral combined hormonal contraceptives in people with Polycystic Ovary Syndrome, run by University of Virginia 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?
The sponsor lists 5 inclusion and 37 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: withdrawn, as of the sponsor's last update on 23 Feb 2026. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score (time frame: baseline). The study lists 2 primary outcomes in all. 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 23 Feb 2026.