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Emergency Contraception and Body Weight: Pilot Study

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ClinicalTrials.gov Identifier: NCT02408692
Recruitment Status : Completed
First Posted : April 3, 2015
Results First Posted : June 2, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Medical Research Foundation, Oregon
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Contraception Body Weight Drug: ECx1 Drug: ECx2 Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Emergency Contraception and Body Weight: Pilot Study
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal BMI ECx1
5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
Drug: ECx1
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.
Other Names:
  • Next choice
  • Emergency Contraception

Active Comparator: Obese BMI ECx1
5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
Drug: ECx1
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.
Other Names:
  • Next choice
  • Emergency Contraception

Active Comparator: Obese BMI ECx2
5 obese women (BMI >30 kg/m2) taking 3mg LNG
Drug: ECx2
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)
Other Names:
  • Next choice
  • Emergency Contraception




Primary Outcome Measures :
  1. Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel [ Time Frame: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5 ]
    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 :
  1. Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel [ Time Frame: Follicular phase of menstrual cycle ]
    Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408692


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Medical Research Foundation, Oregon
Investigators
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Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University

Publications of Results:
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Responsible Party: Alison Edelman, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02408692     History of Changes
Other Study ID Numbers: OHSU IRB 11419
First Posted: April 3, 2015    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: October 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Alison Edelman, Oregon Health and Science University:
Emergency contraception
Obese BMI
Normal BMI
Additional relevant MeSH terms:
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Body Weight
Emergencies
Signs and Symptoms
Disease Attributes
Pathologic Processes