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Emergency Contraception and Body Weight: Pilot Study

Primary Purpose

Contraception, Body Weight

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ECx1
ECx2
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Contraception focused on measuring Emergency contraception, Obese BMI, Normal BMI

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects are between the ages of 18 and 35
  • Subjects are in good general health
  • Subjects have regular menstrual cycles (between 21 and 35 days)
  • Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).

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 (8 week) use of hormonal contraception
  • Current use of drugs that interfere with metabolism of sex steroids
  • Smokers.

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal BMI ECx1

Obese BMI ECx1

Obese BMI ECx2

Arm Description

5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG

5 obese women (BMI >30 kg/m2) taking 1.5mg LNG

5 obese women (BMI >30 kg/m2) taking 3mg LNG

Outcomes

Primary Outcome Measures

Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel

Secondary Outcome Measures

Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel

Full Information

First Posted
March 27, 2015
Last Updated
September 22, 2017
Sponsor
Oregon Health and Science University
Collaborators
Medical Research Foundation, Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT02408692
Brief Title
Emergency Contraception and Body Weight: Pilot Study
Official Title
Emergency Contraception and Body Weight: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Medical Research Foundation, Oregon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
Detailed Description
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations. We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Body Weight
Keywords
Emergency contraception, Obese BMI, Normal BMI

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal BMI ECx1
Arm Type
Active Comparator
Arm Description
5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
Arm Title
Obese BMI ECx1
Arm Type
Active Comparator
Arm Description
5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
Arm Title
Obese BMI ECx2
Arm Type
Active Comparator
Arm Description
5 obese women (BMI >30 kg/m2) taking 3mg LNG
Intervention Type
Drug
Intervention Name(s)
ECx1
Other Intervention Name(s)
Next choice, Emergency Contraception
Intervention Description
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
Intervention Type
Drug
Intervention Name(s)
ECx2
Other Intervention Name(s)
Next choice, Emergency Contraception
Intervention Description
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
Primary Outcome Measure Information:
Title
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Description
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Time Frame
Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Secondary Outcome Measure Information:
Title
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Description
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Time Frame
Follicular phase of menstrual cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are between the ages of 18 and 35 Subjects are in good general health Subjects have regular menstrual cycles (between 21 and 35 days) Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD). 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 (8 week) use of hormonal contraception Current use of drugs that interfere with metabolism of sex steroids Smokers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Edelman, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU. OHSU complies with NIH policy on Sharing Research Data.
Citations:
PubMed Identifier
27000996
Citation
Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.
Results Reference
result

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Emergency Contraception and Body Weight: Pilot Study

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