Obesity, Oral Contraception, and Ovarian Suppression

Ovarian Suppression Clinical Trial

— 20/30  

Official title:

Oral Contraception and Ovarian Suppression in Women With Different Weights

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827632
• Other study ID #: AAAB4823
• Secondary ID: R01HD045786
• Status: Completed
• Phase: Phase 4
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ovarian Suppression
• Vision Disorders

Intervention

Drug:
• Low dose formulation
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.
• High dose formulation
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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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