Ulipristal Acetate 10 mg and Asisted Reproduction

Uterine Fibroids Clinical Trial

Official title:

Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02425878
• Other study ID #: 1311-BCN-138-DG
• Status: Terminated
• Phase: Phase 3
• Start date: October 19, 2015
• Est. completion date: May 31, 2016

Study information

• Verified date: October 2020
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Intramural Fibroids
• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Ulipristal Acetate

• Placebo

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in the rate of clinical pregnancy		12 weeks