Trial Outcomes & Findings for A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity (NCT NCT05061472)
NCT ID: NCT05061472
Last Updated: 2024-12-11
Results Overview
The investigators aim to recruit \~10 women per month for 6 months (N=24; n=12 COCs, n=12 NHCs; \>20% in each group of African American or Hispanic race/ethnicity) and assess feasibility of completion of outcome measures. The investigators hypothesize that at least 80% of participants will continue their chosen contraceptive method and complete outcome measures within a 2-week window at 6 months. The 6-month date was calculated as baseline outcome date + 182 days. A 2-week window was considered a +/- 14 days from the calculated 6-month outcome date.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
Combined Oral Contraceptives
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
Month 0 (Baseline)
STARTED
|
10
|
10
|
|
Month 0 (Baseline)
COMPLETED
|
10
|
10
|
|
Month 0 (Baseline)
NOT COMPLETED
|
0
|
0
|
|
Month 3
STARTED
|
10
|
10
|
|
Month 3
COMPLETED
|
10
|
10
|
|
Month 3
NOT COMPLETED
|
0
|
0
|
|
Month 6 (Final)
STARTED
|
9
|
10
|
|
Month 6 (Final)
COMPLETED
|
9
|
10
|
|
Month 6 (Final)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Baseline characteristics by cohort
| Measure |
Combined Oral Contraceptives
n=10 Participants
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 Participants
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Highest Level of School Completed
12th Grade
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest Level of School Completed
2-year College
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest Level of School Completed
4-year College
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Highest Level of School Completed
Master's Degree
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest Level of School Completed
Doctorate Degree
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest Level of School Completed
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Annual Household Income
< $25,000
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Annual Household Income
$25,000-$45,000
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Annual Household Income
$45,001-$70,000
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Annual Household Income
$70,001-$110,000
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Annual Household Income
> $100,001
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital Status
Single
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital Status
Committed Relationship
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital Status
Married
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
Separated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Reported overweight as child?
Yes
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Reported overweight as child?
No
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Highest reported non-pregnant adult weight
|
185 pounds
n=5 Participants
|
193 pounds
n=7 Participants
|
188 pounds
n=5 Participants
|
|
Age at menarche
|
11.5 years
n=5 Participants
|
12 years
n=7 Participants
|
12 years
n=5 Participants
|
|
Normal periods in the last year?
Yes
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Normal periods in the last year?
No
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ever pregnant?
Yes
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ever pregnant?
No
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Currently Exercising?
Yes
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Currently Exercising?
No
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Currently Using...
Tobacco
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Currently Using...
Alcohol
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Currently Using...
Recreational Drugs
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6The investigators aim to recruit \~10 women per month for 6 months (N=24; n=12 COCs, n=12 NHCs; \>20% in each group of African American or Hispanic race/ethnicity) and assess feasibility of completion of outcome measures. The investigators hypothesize that at least 80% of participants will continue their chosen contraceptive method and complete outcome measures within a 2-week window at 6 months. The 6-month date was calculated as baseline outcome date + 182 days. A 2-week window was considered a +/- 14 days from the calculated 6-month outcome date.
Outcome measures
| Measure |
Combined Oral Contraceptives
n=10 Participants
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 Participants
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
Number of Premenopausal Women With Overweight/Obesity Who Initiated a COC vs. Continued NHC Use, Enrolled and Remained in This Study, and Completed Outcome Measures
Completed 6 Month Measures within a 2-week Time Frame from Baseline Outcome Measure Date
|
9 Participants
|
10 Participants
|
|
Number of Premenopausal Women With Overweight/Obesity Who Initiated a COC vs. Continued NHC Use, Enrolled and Remained in This Study, and Completed Outcome Measures
Did Not Complete 6-Month Measures within a 2-week Time Frame from Baseline Outcome Measure Date
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsBody Weight in pounds (lbs)
Outcome measures
| Measure |
Combined Oral Contraceptives
n=10 Participants
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 Participants
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
Body Weight
Month 0
|
186.3 pounds
Interval 175.8 to 194.2
|
185.1 pounds
Interval 163.3 to 198.5
|
|
Body Weight
Month 6
|
182.5 pounds
Interval 180.9 to 184.6
|
187.7 pounds
Interval 167.3 to 198.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 MonthsBody Mass Index (BMI \[kg/m\^2\]) from dual x-ray absorptiometry
Outcome measures
| Measure |
Combined Oral Contraceptives
n=10 Participants
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 Participants
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
BMI
Month 0
|
30.1 kg/m^2
Interval 28.9 to 33.0
|
30.5 kg/m^2
Interval 28.6 to 31.1
|
|
BMI
Month 6
|
29.3 kg/m^2
Interval 28.6 to 31.1
|
30.8 kg/m^2
Interval 28.8 to 33.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 Months% Body Fat (Fat Mass/Total Mass) as assessed on dual x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Combined Oral Contraceptives
n=10 Participants
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 Participants
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
Percent Body Fat
Month 0
|
42.5 percent
Interval 41.1 to 43.8
|
41.3 percent
Interval 38.4 to 44.6
|
|
Percent Body Fat
Month 6
|
44.4 percent
Interval 41.0 to 45.1
|
43.1 percent
Interval 40.7 to 44.9
|
Adverse Events
Combined Oral Contraceptives
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nonhormonal Contraceptives (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combined Oral Contraceptives
n=10 participants at risk
Pre-menopausal women with overweight or obesity who are newly initiating the norgestimate/ethinyl estradiol 0.25mg/35mcg combined oral contraceptive pill.
|
Nonhormonal Contraceptives (Control)
n=10 participants at risk
Pre-menopausal women with overweight or obesity who are using non-hormonal methods of birth control.
|
|---|---|---|
|
Psychiatric disorders
Changes in Mental Health
|
10.0%
1/10 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
Additional Information
Adnin Zaman, MD
University of Colorado Anschutz Medical Campus
Phone: 5852761001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place