A Phase 3 interventional study of Ulipristal Acetate and Placebo in Intramural Fibroids and Uterine Fibroids, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Terminated at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Phase 3, Interventional, and Treatment
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
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 2 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Drug: Ulipristal Acetate
Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks
Drug: Placebo
increase in the rate of clinical pregnancy
Time frame: 12 weeks
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Instituto Valenciano de Infertilidad, IVI VALENCIA