Impact of Combined Hormonal Contraceptives on UPA

Contraception Clinical Trial

Official title:

Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577601
• Other study ID #: OHSU IRB 11784
• Status: Completed
• Phase: Phase 4
• Start date: September 8, 2015
• Est. completion date: June 17, 2017

Study information

• Verified date: October 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 17, 2017
• Est. primary completion date: June 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ulipristal Acetate

• Levonorgestrel (LNG)/Ethinyl estradiol birth control pill

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Follicle Rupture	Following dosing with UPA, subjects underwent daily visits with ultrasound monitoring until evidence of follicle rupture (complete disappearance or >50% reduction of the mean size of the leading follicle).	within 5 days of taking the study drug