Impact of Combined Hormonal Contraceptives on UPA
|ClinicalTrials.gov Identifier: NCT02577601|
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : December 31, 2018
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Ulipristal Acetate Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate|
|Actual Study Start Date :||September 8, 2015|
|Actual Primary Completion Date :||June 17, 2017|
|Actual Study Completion Date :||June 17, 2017|
Active Comparator: UPA Only
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
No Intervention: Washout Cycle
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
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
Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
- Number of Participants With Follicle Rupture [ Time Frame: within 5 days of taking the study drug ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577601
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alison Edelman, MD||Oregon Health and Science University|