Obesity, Oral Contraception, and Ovarian Suppression

Study Overview
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Brief Summary
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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.

Detailed Description
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There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Official Title
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Oral Contraception and Ovarian Suppression in Women With Different Weights

Conditions
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Ovarian Suppression

Intervention / Treatment
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* Drug: Low dose formulation
* Drug: High dose formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Weight group<br>Participants with a BMI of 19-24.9 kg/m^2 | Drug: Low dose formulation<br>* Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.<br>* Other names: Low dose;Drug: High dose formulation<br>* Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.<br>* Other names: High dose;|
| Active Comparator: Obese group<br>Participants with a BMI of 30-39.9 kg/m^2 | Drug: Low dose formulation<br>* Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonorgestrel (LN) per tablet.<br>* Other names: Low dose;Drug: High dose formulation<br>* Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 30 ug of ethinyl estradiol (EE) and 150 ug of levonorgestrel (LN) per tablet.<br>* Other names: High dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives. |  | 24 hours during week 3 of follow-up cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Suppression, Oral Contraceptives, Obese and Normal BMI