Conditions: Postmenopause
Keywords: Postmenopausal Symptoms e.g. Hot flushes Sweating episodes Vaginal dryness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 662
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). arm 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Interventions: intervention 1: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.5mg NETA / 1.0mg E2 (Activella)
Intervention descriptions: intervention 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). intervention 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Protocol document: