Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
Overview
- Phase
- Phase 4
- Intervention
- UPA-ECx1
- Conditions
- Obesity
- Sponsor
- Oregon Health and Science University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Number of Participants With Delay in Follicular Rupture Beyond 5 Days
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Alison Edelman
Professor, OB/GYN
Oregon Health and Science University
Eligibility Criteria
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
Arms & Interventions
UPA-ECx1 followed by 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.
Intervention: UPA-ECx1
UPA-ECx1 followed by 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.
Intervention: UPA-ECx2
UPA-ECx2 followed by 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.
Intervention: UPA-ECx1
UPA-ECx2 followed by 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.
Intervention: UPA-ECx2
UPA-ECx1 Normal BMI/weight
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
Intervention: UPA-ECx1
Outcomes
Primary Outcomes
Number of Participants With Delay in Follicular Rupture Beyond 5 Days
Time Frame: 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 Outcomes
- Maximum Serum Concentration of Ulipristal Acetate(24 hours)