NCT02425878

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 19, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

April 21, 2015

Last Update Submit

October 13, 2020

Conditions

Intramural FibroidsUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • increase in the rate of clinical pregnancy

    12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks

Drug: Ulipristal Acetate

Control

PLACEBO COMPARATOR

Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks

Drug: Placebo

Interventions

Ulipristal AcetateDRUG
Experimental
PlaceboDRUG
Control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Daniela Galliano, MDPhD

    Instituto Valenciano de Infertilidad, IVI VALENCIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

October 19, 2015

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

ES(1)