EC-Obesity: Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

Sponsor

Oregon Health and Science University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02863445

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

66.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Levonorgestrel-based emergency contraception 1.5 mg Drug: Levonorgestrel-based emergency contraception 3.0mg	Phase 4

Detailed Description

Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.

The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. The hypothesis is that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, the investigators plan to perform detailed pharmacokinetic and pharmacodynamic studies of ulipristal acetate-based EC in obese women and expand upon the preliminary findings of levonorgestrel-based EC. This protocol registration is for the LNG aspect of the study procedures focused on the pharmacodynamics of LNG dose escalation

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - Pharmacodynamics of 3.0mg LNG

Actual Study Start Date :

May 30, 2017

Actual Primary Completion Date :

Jan 16, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LNG-ECx1 Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.	Drug: Levonorgestrel-based emergency contraception 1.5 mg Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC Other Names: Plan B Next Choice
Experimental: LNG-ECx2 Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.	Drug: Levonorgestrel-based emergency contraception 3.0mg Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC

Arm

Intervention/Treatment

Active Comparator: LNG-ECx1

Levonorgestrel 1.5 mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.

Drug: Levonorgestrel-based emergency contraception 1.5 mg

Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC

Other Names:

Plan B

Next Choice

Experimental: LNG-ECx2

Levonorgestrel 3mg orally x 1 dose. Timing of dosage depends on ovarian follicle measurements.

Drug: Levonorgestrel-based emergency contraception 3.0mg

Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC

Outcome Measures

Primary Outcome Measures

The proportion of obese women with no follicle rupture (yes/no) between the two treatment groups (1.5mg levonorgestrel and 3mg levonorgestrel) [1 menstrual cycle (up to a 35 day time period)]
Follicle rupture by ultrasound. Defined as the disappearance of or >50% reduction in the size of the leading follicle.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Generally health women
Aged 18-35 years old
Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.
Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

Exclusion Criteria:

Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
Impaired liver or renal function
Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
Recent (within last 8 weeks) use of hormonal contraception
Current use of drugs that interfere with metabolism of sex steroids
Smokers.