Overview

Impact of Combined Hormonal Contraceptives on UPA

Status:
Completed
Trial end date:
2017-06-17
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this research study is to determine if taking a birth control pill effects how well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of emergency contraceptive is the most effective oral method available. However, this medication is an anti-progestin and most regular forms of birth control contain progestin (a female hormone). It is unknown if taking the two close together may make the emergency contraceptive not work well. The overall goal of this research is to improve the effectiveness of contraception for women and to better counsel women.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Oregon Health and Science University
Collaborator:
Society of Family Planning
Treatments:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Levonorgestrel
Ulipristal acetate
Criteria
Inclusion Criteria:

- Generally healthy women aged 18 to 35 with regular menses (every 21-35 days).

- Normal BMI

- Proven ovulation with a screening serum progesterone of >3ng/mL

- Willing to use condoms (if sexually active with a male partner), willing to not have
sex with men during the study, or have had a tubal ligation (or have a partner who has
had a vasectomy) or have a copper intrauterine device (IUD).

Exclusion Criteria:

- Known intolerance or allergy to any of the study medication

- Known metabolic disorders including polycystic ovarian syndrome or uncontrolled
thyroid disorder

- Overweight or obese BMI

- Any Centers for Disease Control and Prevention (CDC) Medical eligibility criteria
category 3 or 4 for combined oral contraception (COC) use 12.

- Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal
contraception

- Current use of drugs that interfere with metabolism of sex steroids

- Smokers.