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Obesity, Oral Contraception, and Ovarian Suppression (20/30)

Primary Purpose

Ovarian Suppression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low dose formulation
High dose formulation
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Suppression focused on measuring Ovarian Suppression, Oral Contraceptives, Obese and Normal BMI

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal Weight group

Obese group

Arm Description

Participants with a BMI of 19-24.9 kg/m^2

Participants with a BMI of 30-39.9 kg/m^2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.

Full Information

First Posted
January 21, 2009
Last Updated
April 16, 2019
Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00827632
Brief Title
Obesity, Oral Contraception, and Ovarian Suppression
Acronym
20/30
Official Title
Oral Contraception and Ovarian Suppression in Women With Different Weights
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Suppression
Keywords
Ovarian Suppression, Oral Contraceptives, Obese and Normal BMI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Weight group
Arm Type
Active Comparator
Arm Description
Participants with a BMI of 19-24.9 kg/m^2
Arm Title
Obese group
Arm Type
Active Comparator
Arm Description
Participants with a BMI of 30-39.9 kg/m^2
Intervention Type
Drug
Intervention Name(s)
Low dose formulation
Other Intervention Name(s)
Low dose
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
High dose formulation
Other Intervention Name(s)
High dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Description
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.
Time Frame
Up to 8 biweekly visits from start of OCP therapy
Secondary Outcome Measure Information:
Title
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Time Frame
Screening (baseline) and follow-up 1 (exit)
Title
Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.
Time Frame
24 hours during week 3 of follow-up cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Westhoff, MD, MSc
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24156617
Citation
Mayeda ER, Torgal AH, Westhoff CL. Weight and body composition changes during oral contraceptive use in obese and normal weight women. J Womens Health (Larchmt). 2014 Jan;23(1):38-43. doi: 10.1089/jwh.2012.4241. Epub 2013 Oct 24.
Results Reference
derived
PubMed Identifier
20664386
Citation
Westhoff CL, Torgal AH, Mayeda ER, Stanczyk FZ, Lerner JP, Benn EKT, Paik M. Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):275-283. doi: 10.1097/AOG.0b013e3181e79440.
Results Reference
derived

Learn more about this trial

Obesity, Oral Contraception, and Ovarian Suppression

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