Impact of Combined Hormonal Contraceptives on UPA

NCT02577601 | Completed Phase 4 Results DMC

• 1 other identifier: OHSU IRB 11784
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Emergency contraception; Birth Control Pills

Outcome Measures

Primary Outcomes (1)

• 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).

  within 5 days of taking the study drug

Study Arms (3)

UPA Only

ACTIVE COMPARATOR

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

Washout Cycle

NO INTERVENTION

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.

UPA + COC

ACTIVE COMPARATOR

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

Interventions

Ulipristal Acetate DRUG

Also known as: UPA, Ella

UPA + COC; UPA Only

Levonorgestrel (LNG)/Ethinyl estradiol birth control pill DRUG

Also known as: portia (generic), birth control pills

UPA + COC

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

ulipristal acetate; Levonorgestrel; Ethinyl Estradiol-Norgestrel Combination; Drugs, Generic; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethinyl Estradiol; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Results Point of Contact

• Title: Ob/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

mccrimmo@ohsu.edu

503-494-0757

Study Officials

• Alison Edelman, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: October 16, 2015
• Study Start: September 8, 2015
• Primary Completion: June 17, 2017
• Study Completion: June 17, 2017
• Last Updated: November 8, 2019
• Results First Posted: December 31, 2018

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)