Phase 4
N=34
EC PK in Women With Normal and Obese BMI
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02689804 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration — 208.5; 100.8 ng*h/mL — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LNG-EC (Drug); UPA-EC (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration |
208.5; 100.8 | <0.01 sig |
| PRIMARY Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration |
293.5; 362.5 | 0.15 |
| SECONDARY Elimination Half-life of Serum LNG |
27.0; 50.4 | — |
| SECONDARY Elimination Half-life of Serum UPA |
34.9; 65.9 | — |
| SECONDARY Clearance of Serum LNG |
4.8; 9.8 | — |
| SECONDARY Clearance of Serum UPA |
4.1; 3.0 | — |
| SECONDARY Maximum Concentration of Serum LNG |
18.2; 10.8 | — |
| SECONDARY Maximum Concentration of Serum UPA |
89.3; 95.6 | — |
| SECONDARY Time to Maximum Concentration of Serum LNG |
2.0; 3.0 | — |
| SECONDARY Time to Maximum Concentration of Serum UPA |
1.6; 1.5 | — |
Summary
A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.
Eligibility Criteria
Inclusion Criteria
- Women aged 18-45 years
- English-speaking
- BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2
- Regular menstrual cycles
- No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles
- No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle
- Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy
Exclusion Criteria
- Prior allergic reaction to LNG-EC or UPA-EC
- Use of hormonal emergency contraception within the past month
- Women who are currently pregnant or who are currently breastfeeding
- History of cancer other than non-melanoma skin cancer
- Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism
- Use of HAART therapy for management of HIV infection
- Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate
- Current participation in any other trial of an investigational medicine or device in the three months leading up to this study
Data sourced from ClinicalTrials.gov (NCT02689804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.