Ovarian Suppression Clinical Trial
— 20/30Official title:
Oral Contraception and Ovarian Suppression in Women With Different Weights
Verified date | April 2019 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.
Status | Completed |
Enrollment | 226 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Aged 18-35 - Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m^2 - Willing to take birth control pills for 3-4 months - Recent spontaneous pregnancy or cyclic menses Exclusion Criteria: - Contraindications to hormonal contraceptives - Oophorectomy/Polycystic ovary syndrome (PCOS) - Taken oral contraceptives to regulate menses recently - Weight reduction surgery - Used Depo-Provera within the last 12 months - Pregnant or currently breastfeeding - Desiring pregnancy within the next 4 months - Unable to make study visit commitment - Previous participation in this study |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. | Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined): no activity potential activity nonactive follicle-like structure active follicle-like structure luteinized unruptured follicle ovulation Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score. |
Up to 8 biweekly visits from start of OCP therapy | |
Secondary | Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure). | Screening (baseline) and follow-up 1 (exit) | ||
Secondary | Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives. | 24 hours during week 3 of follow-up cycle |