Endometrial Safety Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Postmenopause

Treatments: Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891); Drug: 0.5mg NETA / 1.0mg E2 (Activella)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00522873

310523 (Other Identifier)

91508

2006-006199-39 (EudraCT Number)

Details and patient eligibility

About

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Enrollment: 662 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment)
• Non-hysterectomized women.

Exclusion criteria

• Usual exclusion criteria for hormone therapy apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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662 participants in 2 patient groups

0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Experimental group

Description:

One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Treatment:

Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)

0.5mg NETA / 1.0mg E2 (Activella)

Active Comparator group

Description:

One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Treatment:

Drug: 0.5mg NETA / 1.0mg E2 (Activella)