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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

Tracking Information
First Submitted Date  ICMJE March 27, 2015
First Posted Date  ICMJE April 3, 2015
Results First Submitted Date  ICMJE April 29, 2017
Results First Posted Date  ICMJE June 2, 2017
Last Update Posted Date October 25, 2017
Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
Average increase in free-LNG Cmax between emergency contraception (EC) alone versus EC x 2 in obese group [ Time Frame: Approximately one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
Compare Free-LNG Cmax after administration of EC alone (baseline) between obese and normal BMI women [ Time Frame: Approximately one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emergency Contraception and Body Weight: Pilot Study
Official Title  ICMJE Emergency Contraception and Body Weight: Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Contraception
  • Body Weight
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Normal BMI ECx1
    5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
    Intervention: Drug: ECx1
  • Active Comparator: Obese BMI ECx1
    5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
    Intervention: Drug: ECx1
  • Active Comparator: Obese BMI ECx2
    5 obese women (BMI >30 kg/m2) taking 3mg LNG
    Intervention: Drug: ECx2
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2015)
30
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02408692
Other Study ID Numbers  ICMJE OHSU IRB 11419
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Alison Edelman, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Medical Research Foundation, Oregon
Investigators  ICMJE
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP