Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

Phase 4

Completed

• Conditions: Obesity; Contraception
• Interventions: Drug: UPA-ECx1; Drug: UPA-ECx2

• Registration Number: NCT02859337
• Lead Sponsor: Oregon Health and Science University

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.

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.

Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize 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, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This protocol registration is for the UPA aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Study Start: 2017-05-30
• Primary Completion: 2022-01-13
• Disposition First Submitted: 2022-12-16
• Study Completion: 2023-11-15
• Results First Submitted: 2023-12-12
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Results First Posted: 2024-02-06
• Disposition First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UPA-ECx1 followed by ECx2	UPA-ECx2	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.
UPA-ECx1 Normal BMI/weight	UPA-ECx1	Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
UPA-ECx1 followed by ECx2	UPA-ECx1	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.
UPA-ECx2 followed by ECx1	UPA-ECx1	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.
UPA-ECx2 followed by ECx1	UPA-ECx2	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Delay in Follicular Rupture Beyond 5 Days	1 menstrual cycle, assessed up to 38 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.

Secondary Outcome Measures

Name	Time	Method
Maximum Serum Concentration of Ulipristal Acetate	24 hours	Maximum serum concentration (Cmax) of UPA in participants with BMI \>/=30 kg/m2 with 30 mg UPA, with BMI \>/= 30 kg/m2 with 60 mg UPA, and normal BMI participants with 30mg UPA

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States