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Impact of Combined Hormonal Contraceptives on UPA

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ClinicalTrials.gov Identifier: NCT02577601
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : December 31, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ulipristal Acetate Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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
Other Names:
  • UPA
  • Ella

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
Other Names:
  • UPA
  • Ella

Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
Other Names:
  • portia (generic)
  • birth control pills




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577601


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Alison Edelman, MD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Alison Edelman, Oregon Health and Science University:
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Responsible Party: Alison Edelman, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02577601    
Other Study ID Numbers: OHSU IRB 11784
First Posted: October 16, 2015    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: November 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at Oregon Health & Science University (OHSU). OHSU complies with NIH policy on Sharing Research Data.
Keywords provided by Alison Edelman, Oregon Health and Science University:
Emergency contraception
Birth Control Pills
Additional relevant MeSH terms:
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Levonorgestrel
Ulipristal acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic