Trial Outcomes & Findings for Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG (NCT NCT02863445)
NCT ID: NCT02863445
Last Updated: 2023-06-15
Results Overview
No evidence of follicle rupture achieved by participant in one menstrual (treatment) cycle at 5 days post LNG dosing. Follicle rupture is defined as the disappearance of or \>50% reduction in the size of the leading follicle. Dosing occurred after a dominant follicle measuring 15 mm or greater in at least one dimension was visualized on ultrasound.
COMPLETED
PHASE4
70 participants
5 days post-LNG dosing
2023-06-15
Participant Flow
Recruitment took place at Oregon Health \& Science University and Eastern Virginia Medical School from June 2017 to February 2021. The study recruited healthy individuals aged 18-35 years with regular menstrual cycles (21-35 days) and BMIs higher than 30 with weights of 176 pounds or more.
After enrollment, participants started their treatment cycle at the time of next menses or could delay for 1-2 menstrual cycles if a scheduling conflict occurred. On days 6-8 of the treatment cycle, participants were monitored every other day for follicular activity with transvaginal ultrasonographic examination, as well as blood sampling for progesterone, estradiol, and LH until a dominant follicle measuring 15 mm or greater in at least one dimension was visualized.
Participant milestones
| Measure |
LNG-ECx1
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 1.5 mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
LNG-ECx2
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 3.0mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Baseline characteristics by cohort
| Measure |
LNG-ECx1
n=35 Participants
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 1.5 mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
LNG-ECx2
n=35 Participants
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 3.0mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
28.7 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 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
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Nulligravid
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
BMI
|
37.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
38.8 kg/m^2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
38.0 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Weight (lbs)
|
224.9 pounds
STANDARD_DEVIATION 33.1 • n=5 Participants
|
236.4 pounds
STANDARD_DEVIATION 39.1 • n=7 Participants
|
230.7 pounds
STANDARD_DEVIATION 36.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days post-LNG dosingNo evidence of follicle rupture achieved by participant in one menstrual (treatment) cycle at 5 days post LNG dosing. Follicle rupture is defined as the disappearance of or \>50% reduction in the size of the leading follicle. Dosing occurred after a dominant follicle measuring 15 mm or greater in at least one dimension was visualized on ultrasound.
Outcome measures
| Measure |
LNG-ECx1
n=35 Participants
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 1.5 mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
LNG-ECx2
n=35 Participants
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 3.0mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
|---|---|---|
|
The Number of Participants in Two Treatment Groups (1.5mg Levonorgestrel and 3mg Levonorgestrel) With no Follicle Rupture at 5 Days Within One Menstrual (Treatment) Cycle.
|
18 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 5 daysAmong the participants with follicle rupture before 5 days, the time to rupture was measured and reported for each day up to day 5. If the date of follicle rupture was unclear by ultrasonographic imaging (eg, collapse was seen, but reduction of size was less than 50%), serum hormone levels were used to adjudicate day of ruptures.
Outcome measures
| Measure |
LNG-ECx1
n=35 Participants
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 1.5 mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
LNG-ECx2
n=35 Participants
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 3.0mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
|---|---|---|
|
Number of Participants With Follicle Rupture Before 5 Days
|
17 Participants
|
11 Participants
|
Adverse Events
LNG-ECx1
LNG-ECx2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LNG-ECx1
n=35 participants at risk
Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 1.5 mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
LNG-ECx2
n=35 participants at risk
Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.
Levonorgestrel-based emergency contraception 3.0mg: Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
|
|---|---|---|
|
Reproductive system and breast disorders
Menstrual Cramping
|
5.7%
2/35 • 90 days
|
5.7%
2/35 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • 90 days
|
17.1%
6/35 • 90 days
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • 90 days
|
5.7%
2/35 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
5.7%
2/35 • 90 days
|
2.9%
1/35 • 90 days
|
|
General disorders
Abdominal Cramping
|
5.7%
2/35 • 90 days
|
5.7%
2/35 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
8.6%
3/35 • 90 days
|
2.9%
1/35 • 90 days
|
Additional Information
Dr. Alison Edelman
Oregon Health and Science University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place