Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

NCT02863445 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OHSU IRB 16291
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Body weight; Emergency contraception; Levonogestrel; Ulipristal acetate

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  5 days post-LNG dosing

Secondary Outcomes (1)

• Number of Participants With Follicle Rupture Before 5 Days

  5 days

Study Arms (2)

LNG-ECx1

ACTIVE COMPARATOR

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

Drug: Levonorgestrel-based emergency contraception 1.5 mg

LNG-ECx2

EXPERIMENTAL

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

Drug: Levonorgestrel-based emergency contraception 3.0mg

Interventions

Levonorgestrel-based emergency contraception 1.5 mg DRUG

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

Also known as: Plan B, Next Choice

LNG-ECx1

Levonorgestrel-based emergency contraception 3.0mg DRUG

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

LNG-ECx2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 27000996 BACKGROUND

• 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.

  PMID: 35849455 RESULT

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Alison Edelman
• Organization: Oregon Health and Science University

edelmana@ohsu.edu

503-494-3666

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, OB/GYN

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 11, 2016
• Study Start: July 6, 2017
• Primary Completion: January 16, 2021
• Study Completion: August 16, 2021
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)