Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results

Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results. - ulipristal acetate 10 mg and Asisted Reproduction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000964-16-ES

Enrollment

282

Registered

2014-07-04

Start date

2015-03-30

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids and Assisted Reproduction

Interventions

Trade Name: Esmya Pharmaceutical Form: Tablet INN or Proposed INN: Ulipristal acetate CAS Number: 126784-99-4 Other descriptive name: ULIPRISTAL ACETATE Concentration unit: MBq/mg megabecquerel(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients> 18 and 2 cm and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: Check ifthere are significant differences in the proportions of evolutionary gestation rate of clinical and biochemical abortions and ectopic pregnancy rate due to treatment with Ulpristal. Assess volume reduction / fibroid (pre and post tto) for 3D / 3D ultrasound measuring 2D. Assess the change in the levels of E2, P4 and FSH (pre and post tto) Rate the change in pain reported by the patients in the study with VAS (pre and post tto) Assess and record the most common side effects of Esmya (see Side Effects section).;Primary end point(s): Evolutionary gestation;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year	—

Measure

Time frame

Main Objective: 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;Secondary Objective: Check ifthere are significant differences in the proportions of evolutionary gestation rate of clinical and biochemical abortions and ectopic pregnancy rate due to treatment with Ulpristal. Assess volume reduction / fibroid (pre and post tto) for 3D / 3D ultrasound measuring 2D. Assess the change in the levels of E2, P4 and FSH (pre and post tto) Rate the change in pain reported by the patients in the study with VAS (pre and post tto) Assess and record the most common side effects of Esmya (see Side Effects section).;Primary end point(s): Evolutionary gestation;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year

—

Secondary

Measure	Time frame
Secondary end point(s): biochemical pregnancy clinical pregnancy Implantation rate ectopic pregnancy Abortion biochemical Abortion clinic;Timepoint(s) of evaluation of this end point: Patients will be recruited for a year	—

Countries

Spain

Contacts

Public ContactDaniela Galliano

IVI Valencia

Daniela.Galliano@ivi.es+34963050900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026