Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
| Status: | Recruiting |
|---|---|
| Conditions: | Contraception, Contraception, Obesity Weight Loss, Hospital |
| Therapuetic Areas: | Endocrinology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 9/27/2018 |
| Start Date: | May 30, 2017 |
| End Date: | October 2021 |
| Contact: | Women's Health Research Unit Department of OB/GYN |
| Email: | whru@ohsu.edu |
| Phone: | 503-494-3666 |
Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
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.
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.
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.
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.
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.
We found this trial at
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