Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD045786 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Weight group | Active Comparator | Participants with a BMI of 19-24.9 kg/m^2 |
|
| Obese group | Active Comparator | Participants with a BMI of 30-39.9 kg/m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose formulation | Drug | 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. |
| 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):
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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Westhoff, MD, MSc | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24156617 | Derived | 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. | |
| 20664386 | Derived | 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. |
Not provided
Not provided
Eligible women were aged 18-35 years with a recent history of regular, spontaneous menstrual cycles, and agreed to use an Oral Contraceptive Pill (OCP) for 3 to 4 months and undergo eight biweekly study visits during the third or fourth OCP cycle.
Participant-related activities were conducted between July 2006-December 2008 in New York City
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normal Weight | Participants with a Body Mass Index (BMI) of 19-24.9. |
| FG001 | Obese | Participants with a Body Mass Index (BMI) of 30-39.9. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Weight | Participants with a Body Mass Index (BMI) of 19-24.9. |
| BG001 | Obese | Participants with a Body Mass Index (BMI) of 30-39.9. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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):
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. | Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese). | Posted | Number | Participants | Up to 8 biweekly visits from start of OCP therapy |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Weight | Participants with a Body Mass Index (BMI) of 19-24.9. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Westhoff | Columbia University | 212-305-4805 | clw3@columbia.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D003271 | Contraceptive Agents, Female |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| High dose formulation | Drug | 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. |
|
|
| 24 hours during week 3 of follow-up cycle |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Oral Contraceptive Pill Compliance | Number | Participants |
|
Participants with a Body Mass Index (BMI) of 19-24.9.
| OG001 | Obese | Participants with a Body Mass Index (BMI) of 30-39.9. |
|
|
| Secondary | Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure). | We excluded participants who were not compliant with the study treatment (based on measuring serum hormone concentrations) from the analyses. | Posted | Mean | Standard Deviation | mg/dL | Screening (baseline) and follow-up 1 (exit) |
|
|
|
| Secondary | Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives. | Data were not available. No analysis performed. | Posted | 24 hours during week 3 of follow-up cycle |
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Obese | Participants with a Body Mass Index (BMI) of 30-39.9. | 0 | 54 | 0 | 54 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| Baseline Lipid - Total Cholesterol |
|
| Exit Lipid - Total Cholesterol |
|