Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

Obesity Clinical Trial

— UPA-Obesity  

Official title:

Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859337
• Other study ID #: OHSU IRB 016291
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2017
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 15, 2023
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Contraception
• Emergencies
• Obesity

Intervention

Drug:
• UPA-ECx1
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
• UPA-ECx2
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Serum Concentration of Ulipristal Acetate	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	24 hours