Inositol Supplementation to Treat Polycystic Ovary Syndrome: A Double Blind Dose Ranging RCT (INSUPP-PCOS)
Who is this study for? Patients with polycystic ovary syndrome
What treatments are being studied? Inositol
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year.
• Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10.
• Women with Polycystic Ovaries on Ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm.
Locations
United States
Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
RECRUITING
Hershey
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Amyee McMonagle, BSN
amcmonagle@pennstatehealth.psu.edu
717-531-4484
Backup
Sandra Eyer
717-531-6208
Time Frame
Start Date: 2020-01-24
Estimated Completion Date: 2025-12-10
Participants
Target number of participants: 154
Treatments
Placebo_comparator: Placebo Treatment bid
Women with PCOS (N = 30) will receive the daily placebo (maltodextrin and inulin) in an identical fashion as the active study group and will be monitored the same.
Experimental: Active Treatment with Inositol 1gm/bid
Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 1000 mg of myo-inositol and 25 mg of d-chiro-inositol) over the initial 3 mos RCT period.
Experimental: Active Treatment with Inositol 2 gm/bid
Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 2000 mg of myo-inositol and 50 mg of d-chiro-inositol) over the initial 3 mos RCT period.
Experimental: Active Treatment with Inositol 3 gm/bid
Women with PCOS (N = 30) will receive daily inositol powder BID as active drug (each dose with 3000 mg of myo-inositol and 75 mg of d-chiro-inositol) over the initial 3 mos RCT period.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: Milton S. Hershey Medical Center