Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

NCT ID: NCT02863445

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-06
• Study Completion Date: 2021-08-16

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.

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LNG-ECx1

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

Group Type: ACTIVE_COMPARATOR

Levonorgestrel-based emergency contraception 1.5 mg

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Levonorgestrel-based emergency contraception 3.0mg

Intervention Type: DRUG

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

Interventions

Levonorgestrel-based emergency contraception 1.5 mg

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

Intervention Type: DRUG

Levonorgestrel-based emergency contraception 3.0mg

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

Intervention Type: DRUG

Other Intervention Names

Plan B; Next Choice

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Professor, OB/GYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison Edelman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

OHSU

Portland, Oregon, United States

Countries

United States

References

Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.

Reference Type: BACKGROUND

PMID: 27000996 (View on PubMed)

Edelman AB, Hennebold JD, Bond K, Lim JY, Cherala G, Archer DF, Jensen JT. Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jul 1;140(1):48-54. doi: 10.1097/AOG.0000000000004717. Epub 2022 Jun 7.

Reference Type: RESULT

PMID: 35849455 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OHSU IRB 16291

Identifier Type: -

Identifier Source: org_study_id