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Emergency Contraception and Body Weight: Pilot Study

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ClinicalTrials.gov Identifier: NCT02408692
Recruitment Status : Completed
First Posted : April 3, 2015
Results First Posted : June 2, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Medical Research Foundation, Oregon
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Contraception
Body Weight
Interventions Drug: ECx1
Drug: ECx2
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Hide Arm/Group Description

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.

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.

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)

Period Title: Overall Study
Started 5 5 5
Completed 5 5 5
Not Completed 0 0 0
Arm/Group Title Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2 Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 5 5 5 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
5
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
Female
5
 100.0%
5
 100.0%
5
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 5 participants 15 participants
5
 100.0%
5
 100.0%
5
 100.0%
15
 100.0%
1.Primary Outcome
Title Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Hide Description Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Time Frame Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 5 5 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
10.3  (2.47) 5.57  (2.76)
2.Secondary Outcome
Title Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Hide Description Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Time Frame Follicular phase of menstrual cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 0 5 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.57  (2.48) 10.52  (2.76)
Time Frame 30 minutes after study medication dosing.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Hide Arm/Group Description

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.

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.

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)

All-Cause Mortality
Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal BMI ECx1 Obese BMI ECx1 Obese BMI ECx2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)      0/5 (0.00%)    
Gastrointestinal disorders       
Emesis   1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alison Edelman
Organization: Oregon Health & Science University
Phone: 503-494-3666
EMail: whru@ohsu.edu
Layout table for additonal information
Responsible Party: Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02408692     History of Changes
Other Study ID Numbers: OHSU IRB 11419
First Submitted: March 27, 2015
First Posted: April 3, 2015
Results First Submitted: April 29, 2017
Results First Posted: June 2, 2017
Last Update Posted: October 25, 2017