Emergency Contraception and Body Weight: Pilot Study

NCT02408692 | Completed Phase 4 Results DMC

• 1 other identifier: OHSU IRB 11419
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception; Body Weight

Keywords

Emergency contraception; Obese BMI; Normal BMI

Outcome Measures

Primary Outcomes (1)

• 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

  Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5

Secondary Outcomes (1)

• Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel

  Follicular phase of menstrual cycle

Study Arms (3)

Normal BMI ECx1

ACTIVE COMPARATOR

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

Drug: ECx1

Obese BMI ECx1

ACTIVE COMPARATOR

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

Drug: ECx1

Obese BMI ECx2

ACTIVE COMPARATOR

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

Drug: ECx2

Interventions

ECx1 DRUG

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.

Also known as: Next choice, Emergency Contraception

Normal BMI ECx1; Obese BMI ECx1

ECx2 DRUG

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)

Also known as: Next choice, Emergency Contraception

Obese BMI ECx2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medical Research Foundation, Oregon: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 27000996 RESULT

MeSH Terms

Conditions

Body Weight

Interventions

Contraception, Postcoital

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics

Results Point of Contact

• Title: Dr. Alison Edelman
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Alison Edelman, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 25, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)