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Phase 4 N=36 Basic Science

Impact of Combined Hormonal Contraceptives on UPA

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT02577601 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants With Follicle Rupture — 1; 9 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ulipristal Acetate (Drug); Levonorgestrel (LNG)/Ethinyl estradiol birth control pill (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Oregon Health and Science University
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Follicle Rupture		 1; 9 —

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02577601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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