Impact of Combined Hormonal Contraceptives on UPA

Study Overview
=================
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.

Official Title
-----------------
Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Ulipristal Acetate
* Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UPA Only<br>During the first treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10). Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. | Drug: Ulipristal Acetate<br> <br> * Other names: Ella;|
| No Intervention: Washout Cycle<br>The month following this first treatment month (washout-cycle),there will be no study visits during this menstrual cycle but there will be contact with study staff (1 or 2 times) by telephone or email to discuss any health changes that are experiencing. | |
| Active Comparator: UPA + COC<br>During the second treatment month, 1 dose of the study medication ulipristal acetate (UPA) will be given when the follicle is a certain size (approximately cycle day 10) and then 2 days later start birth control pills. Following this, there will be daily study visits for 7 days unless evidence of ovulation occurs earlier. | Drug: Ulipristal Acetate<br> <br> * Other names: Ella;Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill<br> <br> * Other names: birth control pills;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency contraception, Birth Control Pills