Impact of Combined Hormonal Contraceptives on UPA
Completed · Phase 4
Conditions studied: Contraception
In brief
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.
Key facts
- Study ID
- NCT02577601
- Run by
- Oregon Health and Science University
- People needed
- 36
- Starts
- 2015-09-08
- Expected to finish
- 2017-06-17
- Last updated by the study team
- 2019-11-08
Who can join
Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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