Trial Outcomes & Findings for Emergency Contraception and Body Weight: Pilot Study (NCT NCT02408692)
NCT ID: NCT02408692
Last Updated: 2017-10-25
Results Overview
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Results posted on
2017-10-25
Participant Flow
Participant milestones
| Measure |
Normal BMI ECx1
5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx1
5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx2
5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Emergency Contraception and Body Weight: Pilot Study
Baseline characteristics by cohort
| Measure |
Normal BMI ECx1
n=5 Participants
5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx1
n=5 Participants
5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx2
n=5 Participants
5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Outcome measures
| Measure |
Normal BMI ECx1
n=5 Participants
5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx1
n=5 Participants
5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx2
5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
|
|---|---|---|---|
|
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
|
10.3 ng/mL
Standard Deviation 2.47
|
5.57 ng/mL
Standard Deviation 2.76
|
—
|
SECONDARY outcome
Timeframe: Follicular phase of menstrual cyclePharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Outcome measures
| Measure |
Normal BMI ECx1
5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx1
n=5 Participants
5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx2
n=5 Participants
5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
|
|---|---|---|---|
|
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
|
—
|
5.57 ng/mL
Standard Deviation 2.48
|
10.52 ng/mL
Standard Deviation 2.76
|
Adverse Events
Normal BMI ECx1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Obese BMI ECx1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese BMI ECx2
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 |
Normal BMI ECx1
n=5 participants at risk
5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx1
n=5 participants at risk
5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of \<25 kg/m2 will have completed study participation.
|
Obese BMI ECx2
n=5 participants at risk
5 obese women (BMI \>30 kg/m2) taking 3mg LNG
ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
|
|---|---|---|---|
|
Gastrointestinal disorders
Emesis
|
20.0%
1/5 • Number of events 1 • 30 minutes after study medication dosing.
|
0.00%
0/5 • 30 minutes after study medication dosing.
|
0.00%
0/5 • 30 minutes after study medication dosing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place