A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Allergan

Status and phase: Completed; Phase 3

Conditions: Leiomyoma; Uterine Hemorrhage

Treatments: Drug: Placebo; Drug: Ulipristal acetate (UPA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02147197

UL1309

Details and patient eligibility

About

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Enrollment: 157 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal women, 18-50 years, inclusive.
• Cyclic abnormal uterine bleeding (heavy or prolonged).
• Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
• Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
• Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia

Exclusion criteria

• History of uterine surgery that would interfere with the study endpoints.
• Known coagulation disorder including bleeding disorder or clotting disorder.
• History of, or current uterine, cervix, ovarian, or breast cancer.
• Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal rang

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 3 patient groups, including a placebo group

UPA 5 mg

Experimental group

Description:

Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.

Treatment:

Drug: Ulipristal acetate (UPA)

Drug: Placebo

UPA 10 mg

Experimental group

Description:

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.

Treatment:

Drug: Ulipristal acetate (UPA)

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.

Treatment:

Drug: Placebo