CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 114 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Metformin 2000 mg daily (step-up titration: 500 mg daily, increased by 500 mg every 5 days to 2000 mg total)AI-extracted
Key inclusion· 4
  • ✓Spontaneous intermenstrual periods of 45 days or longer, or 8 or fewer periods per year
  • ✓Elevated testosterone levels
  • ✓General good health
  • ✓Off current medications that may confound response to study medications
Key exclusion· 5
  • ✕Pregnancy
  • ✕Lactose intolerance
  • ✕Medical contraindications to study drugs
  • ✕Elevated prolactin, 17-hydroxyprogesterone, or follicle-stimulating hormone on blood tests

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00151411
NCT00151411Phase 2Completed
CompareCT.gov

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Milton S. Hershey Medical Center·interventional·Posted Sep 9, 2005·Updated Mar 21, 2018

In Brief

A Phase 2 clinical trial evaluating Metformin, Placebo, and 1 other intervention for Polycystic Ovary Syndrome. Completed, enrolled 114 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartOct 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

Metformindrug

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

Placebodrug

Placebo

Lifestyle Interventionbehavioral

A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.