Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Hospital |
| Therapuetic Areas: | Endocrinology, Other |
| 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 - Pharmacodynamics of 3.0mg LNG
Obese women are significantly more likely than their normal BMI counterparts to experience
failure of orally-dosed emergency contraceptives. The PI's 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. The overall project will be focused on
both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but
this protocol registration is for the LNG aspect of the study procedures.
failure of orally-dosed emergency contraceptives. The PI's 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. The overall project will be focused on
both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but
this protocol registration is for the LNG 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.
The PI's preliminary data provides evidence for testing a dose escalation strategy in an
effort to provide improved efficacy from orally-dosed EC in obese women. The hypothesis is
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, the investigators plan to perform detailed pharmacokinetic and
pharmacodynamic studies of ulipristal acetate-based EC in obese women and expand upon the
preliminary findings of levonorgestrel-based EC. This protocol registration is for the LNG
aspect of the study procedures focused on the pharmacodynamics of LNG dose escalation
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.
The PI's preliminary data provides evidence for testing a dose escalation strategy in an
effort to provide improved efficacy from orally-dosed EC in obese women. The hypothesis is
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, the investigators plan to perform detailed pharmacokinetic and
pharmacodynamic studies of ulipristal acetate-based EC in obese women and expand upon the
preliminary findings of levonorgestrel-based EC. This protocol registration is for the LNG
aspect of the study procedures focused on the pharmacodynamics of LNG dose escalation
Inclusion Criteria:
- Generally health women
- Aged 18-35 years old
- Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a
progesterone level of 3ng/ml or greater.
- Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.
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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