Contraception
Conditions
Keywords
Emergency contraception, Birth Control Pills
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.
Interventions
DRUGUlipristal Acetate
DRUGLevonorgestrel (LNG)/Ethinyl estradiol birth control pill
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Follicle Rupture | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Cycles 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. Cycle 1: Ulipristal Acetate
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.
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. Cycle 3: Ulipristal Acetate and Levonorgestrel (LNG)/Ethinyl estradiol birth control pill | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | All Cycles |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 28.4 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 1 / 36 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 36 | 0 / 33 | 0 / 33 |
Outcome results
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).
Time frame: within 5 days of taking the study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UPA Only | Number of Participants With Follicle Rupture | 1 Participants |
| UPA + COC | Number of Participants With Follicle Rupture | 9 Participants |