Clinical trial NCT02577601: Impact of Combined Hormonal Contraceptives on UPA
Official title: Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Emergency contraception
Birth Control Pills
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2015-10-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Emergency contraception (EC) provides women with an additional line of defense against unintended pregnancy during an act of unprotected intercourse. An antiprogestin, ulipristal acetate (UPA; ellaTM), has emerged as one of the most effective oral options. However, there is currently a lack of information regarding the practical use of UPA. Basic science studies have shown that UPA binds to and prevents progesterone receptor from working, leading to the possible concern that hormonal contraceptives, like the birth control pill, would prevent UPA from working. Ideally, women should start their regular method of birth control soon after EC use but by doing this, they may prevent the UPA EC from working. A woman could just delay starting her regular method of birth control but then she is still at risk for pregnancy.

This proposal has been designed to address this gap in knowledge and will focus on the impact of the birth control pill on UPA's ability to delay ovulation (or the release of an egg). Subjects will undergo a referent cycle UPA only (Cycle 1, 1 month), followed by a washout cycle (Cycle 2, 1 month) and finally UPA with combined oral contraceptives (COCs) dosed 2 days later (Cycle 3, 1 month treatment cycle). The hypothesis is that starting the birth control pill shortly after UPA adversely impacts UPA's ability to delay ovulation.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Follicle Rupture
timeFrame: within 5 days of taking the study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD
role: PRINCIPAL_INVESTIGATOR
References: