Conditions: Secondary Amenorrhea
Keywords: To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PROMETRIUM® 300 mg intervention 2: PROMETRIUM® 400 mg
Intervention descriptions: intervention 1: 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles intervention 2: 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

Protocol document: