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New treatment option for Polycystic Ovary Syndrome
Official title Acupuncture or Metformin for Insulin Resistance in Women With PCOS
ClinicalTrials.gov ID: NCT02647827
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycystic ovary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- women with PCOS:
- Age 18 to 40 years
- Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).
- PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism...
- Willing to sign the consent form.
You likely can't join if
- for all women
- Age \>40
- Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), androgen secreting...
- Having known renal disease (creatinine clearance \< 60 mL/min), hepatic insufficiency, autoimmune disorders or cancer.
- Any acute condition with potential to alter renal function or cause tissue hypoxia.
- Type I diabetes.
See the full eligibility criteria
- women with PCOS:
- Age 18 to 40 years
- Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).
- PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism (hirsutism or acne); oligo/amenorrhea; and/or polycystic ovaries (PCOS)...
- Willing to sign the consent form.
- controls: Controls should have BMI \>25 to \ 4), or evidence of PCO morphology on ultrasound.
- for all women
- Age \>40
- Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), androgen secreting tumors or suspected Cushing's syndrome.
- Having known renal disease (creatinine clearance \< 60 mL/min), hepatic insufficiency, autoimmune disorders or cancer.
- Any acute condition with potential to alter renal function or cause tissue hypoxia.
- Type I diabetes.
- Pharmacological treatment (cortizon, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator)...
- Hypersensitivity to metformin hydrochloride or to any of the excipients.
- Blood pressure \>160 / 100 mmHg
- Pregnancy or breastfeeding the last 6 months
- Acupuncture the last 2 months
- Daily smoking and alcoholic intake
- Language barrier or disabled person with reduced ability to understand the information given. In total 50 controls will be matched at baseline (age, weight and BMI) to women with PCOS. Controls will undergo screening...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.