A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for 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

NCT02147158

UL1208

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: 432 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal 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 range.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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432 participants in 6 patient groups

UPA 5 mg:Placebo

Experimental group

Description:

Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)

UPA 10 mg:Placebo

Experimental group

Description:

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)

UPA 5 mg:UPA 5 mg

Experimental group

Description:

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)

UPA 10 mg:UPA 10 mg

Experimental group

Description:

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)

Placebo:UPA 5 mg

Experimental group

Description:

Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)

Placebo:UPA 10 mg

Experimental group

Description:

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Treatment:

Drug: Placebo

Drug: Ulipristal acetate (UPA)