Trial Outcomes & Findings for Obesity, Oral Contraception, and Ovarian Suppression (NCT NCT00827632)
NCT ID: NCT00827632
Last Updated: 2019-04-30
Results Overview
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): 1. no activity 2. potential activity 3. nonactive follicle-like structure 4. active follicle-like structure 5. luteinized unruptured follicle 6. 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.
COMPLETED
PHASE4
226 participants
Up to 8 biweekly visits from start of OCP therapy
2019-04-30
Participant Flow
Participant-related activities were conducted between July 2006-December 2008 in New York City
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 milestones
| Measure |
Normal Weight
Participants with a Body Mass Index (BMI) of 19-24.9.
|
Obese
Participants with a Body Mass Index (BMI) of 30-39.9.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
98
|
|
Overall Study
COMPLETED
|
106
|
75
|
|
Overall Study
NOT COMPLETED
|
22
|
23
|
Reasons for withdrawal
| Measure |
Normal Weight
Participants with a Body Mass Index (BMI) of 19-24.9.
|
Obese
Participants with a Body Mass Index (BMI) of 30-39.9.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
12
|
|
Overall Study
Early withdrawal
|
14
|
11
|
Baseline Characteristics
Obesity, Oral Contraception, and Ovarian Suppression
Baseline characteristics by cohort
| Measure |
Normal Weight
n=106 Participants
Participants with a Body Mass Index (BMI) of 19-24.9.
|
Obese
n=75 Participants
Participants with a Body Mass Index (BMI) of 30-39.9.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic African American
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-compliant OCP users (dropped from analysis)
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Oral Contraceptive Pill Compliance
Consistent Users
|
96 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Oral Contraceptive Pill Compliance
Inconsistent Users
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Oral Contraceptive Pill Compliance
Nonusers
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 biweekly visits from start of OCP therapyPopulation: Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).
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): 1. no activity 2. potential activity 3. nonactive follicle-like structure 4. active follicle-like structure 5. luteinized unruptured follicle 6. 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.
Outcome measures
| Measure |
Normal Weight
n=96 Participants
Participants with a Body Mass Index (BMI) of 19-24.9.
|
Obese
n=54 Participants
Participants with a Body Mass Index (BMI) of 30-39.9.
|
|---|---|---|
|
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Score of 1 - no activity
|
54 Participants
|
28 Participants
|
|
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Score of 2 - potential activity
|
11 Participants
|
12 Participants
|
|
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Score of 3 - nonactive follicle-like structure
|
6 Participants
|
6 Participants
|
|
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Score of 4 - active follicle-like structure
|
21 Participants
|
7 Participants
|
|
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
Score of 5/6 - luteinization or ovulation
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening (baseline) and follow-up 1 (exit)Population: We excluded participants who were not compliant with the study treatment (based on measuring serum hormone concentrations) from the analyses.
Outcome measures
| Measure |
Normal Weight
n=96 Participants
Participants with a Body Mass Index (BMI) of 19-24.9.
|
Obese
n=54 Participants
Participants with a Body Mass Index (BMI) of 30-39.9.
|
|---|---|---|
|
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Baseline Lipid - Total Cholesterol
|
171.4 mg/dL
Standard Deviation 25.9
|
177.0 mg/dL
Standard Deviation 27.2
|
|
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Baseline Carbohydrate - Glucose
|
87.2 mg/dL
Standard Deviation 8.6
|
90.2 mg/dL
Standard Deviation 7.1
|
|
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Exit Carbohydrate - Glucose
|
89.8 mg/dL
Standard Deviation 8.5
|
92.7 mg/dL
Standard Deviation 10.5
|
|
Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
Exit Lipid - Total Cholesterol
|
172.3 mg/dL
Standard Deviation 27.3
|
170.4 mg/dL
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: 24 hours during week 3 of follow-up cyclePopulation: Data were not available. No analysis performed.
Outcome measures
Outcome data not reported
Adverse Events
Normal Weight
Obese
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place