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NCT02577601

Impact of Combined Hormonal Contraceptives on UPA

Completed Phase 4 Results posted Last updated 8 November 2019
What this trial tests

Phase 4 trial testing Ulipristal Acetate in Contraception in 36 participants. Completed in 17 June 2017.

Timeline
8 September 2015
Primary endpoint
17 June 2017
17 June 2017

Quick facts

Lead sponsorOregon Health and Science University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment36
Start date8 September 2015
Primary completion17 June 2017
Estimated completion17 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 35, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Follicle Rupture Primary · 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).

GroupValue95% CI
UPA Only1
UPA + COC9

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

UPA Only
Serious: 0/36 (0%)
Deaths: 0/36
Washout Cycle
Serious: 0/33 (0%)
Deaths: 0/33
UPA + COC
Serious: 0/33 (0%)
Deaths: 0/33
Other adverse events (1 terms — click to expand)

ReactionSystemUPA OnlyWashout CycleUPA + COC
Malar rashSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02577601 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for emergency contraception.
    Shen J, Che Y, Showell E, Chen K, et al · · 2019 · cited 34× · PMID 30661244 · DOI 10.1002/14651858.cd001324.pub6
  2. Interventions for emergency contraception.
    Shen J, Che Y, Showell E, Chen K, et al · · 2017 · cited 14× · PMID 28766313 · DOI 10.1002/14651858.cd001324.pub5

Verify or expand the search:

Other trials of Ulipristal Acetate

Trials testing the same drug.

Other recruiting trials for Contraception

Currently open trials in the same condition.

Other Oregon Health and Science University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02577601.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing