Impact of Combined Hormonal Contraceptives on UPA
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 1/2/2019 |
| Start Date: | September 8, 2015 |
| End Date: | June 17, 2017 |
Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate
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.
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.
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.
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.
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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-494-3666
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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