UPA-Obesity: Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

Sponsor

Oregon Health and Science University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02859337

Collaborator

National Institutes of Health (NIH) (NIH)

112

Enrollment

Location

Arms

67.1

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Contraception	Drug: UPA-ECx1 Drug: UPA-ECx2	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 30, 2017

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: UPA-ECx1 Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC Other Names: Ella Ella-One Drug: UPA-ECx2 Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC Other Names: ella ella-one
Experimental: 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.	Drug: UPA-ECx1 Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC Other Names: Ella Ella-One Drug: UPA-ECx2 Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC Other Names: ella ella-one
Other: 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.	Drug: UPA-ECx1 Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC Other Names: Ella Ella-One

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: UPA-ECx1

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

Other Names:

Ella

Ella-One

Drug: UPA-ECx2

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

Other Names:

ella

ella-one

Experimental: 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.

Drug: UPA-ECx1

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

Other Names:

Ella

Ella-One

Drug: UPA-ECx2

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

Other Names:

ella

ella-one

Other: 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.

Drug: UPA-ECx1

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

Other Names:

Ella

Ella-One

Outcome Measures

Primary Outcome Measures

Delay in follicular rupture [1 menstrual cycle]
Follicular rupture (yes/no) by ultrasound between treatment groups (30 vs 60 mg of UPA). Defined as the disappearance of or >50% reduction in size of the leading follicle

Secondary Outcome Measures

Maximum serum concentration [24 hours]
Maximum serum concentration (Cmax) of obese users of 30 versus 60 mg of UPA and between obese and normal BMI users of 30mg UPA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.