Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

NCT02859337 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OHSU IRB 016291
• Study Type: interventional
• Target: 64
• 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. Our 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. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Conditions

Obesity; Contraception

Keywords

obesity; body weight; BMI; emergency contraception; levonorgestrel; ulipristal acetate

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Delay in Follicular Rupture Beyond 5 Days

  Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI \>/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or \>50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero.

  1 menstrual cycle, assessed up to 38 days

Secondary Outcomes (1)

• Maximum Serum Concentration of Ulipristal Acetate

  24 hours

Study Arms (3)

UPA-ECx1 followed by ECx2

ACTIVE COMPARATOR

Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.

Drug: UPA-ECx1; Drug: UPA-ECx2

UPA-ECx2 followed by ECx1

EXPERIMENTAL

Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.

Drug: UPA-ECx1; Drug: UPA-ECx2

UPA-ECx1 Normal BMI/weight

OTHER

Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.

Drug: UPA-ECx1

Interventions

UPA-ECx1 DRUG

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC

Also known as: Ella, Ella-One

UPA-ECx1 Normal BMI/weight; UPA-ECx1 followed by ECx2; UPA-ECx2 followed by ECx1

UPA-ECx2 DRUG

Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC

Also known as: ella, ella-one

UPA-ECx1 followed by ECx2; UPA-ECx2 followed by ECx1

Eligibility Criteria

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

You may qualify if:

• Generally healthy women
• Aged 18-35 years old
• Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
• Subjects must have a BMI of \>30kg/m2 and weight at least 80kg or more OR a BMI \<25kg/m2 and a weight of less than 80kg.

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

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. A Edelman
• Organization: Oregon Health & Science University

edelmana@ohsu.edu

503-418-2585

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, OB/GYN

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: May 30, 2017
• Primary Completion: January 13, 2022
• Study Completion: November 15, 2023
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)