NCT02425878TerminatedPhase 3
Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 country2 target enrollmentStarted: October 19, 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- increase in the rate of clinical pregnancy
Study Overview
Brief Summary
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery
Exclusion Criteria
- •History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study
Arms & Interventions
Experimental
Experimental
Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Intervention: Ulipristal Acetate (Drug)
Control
Placebo Comparator
Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
increase in the rate of clinical pregnancy
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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