To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
Secretory Conversion of the Endometrium
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Time frame: End of the study (Days 85)
Number of Subjects With Withdrawal Bleeding
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
Time frame: After first and second cycle (cycle=28 days)
Maximum Intensity of Withdrawal Bleeding After Any Cycle
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
Time frame: Duration of withdrawal bleed
The Duration of Withdrawal Bleeding After the First Treatment Cycle
The numbers of days the subjects actually bled after the end of the first treatment cycle.
Time frame: End of the first cycle of treatment (cycle=28 days)
The Duration of Withdrawal Bleeding After Second Treatment Cycle
The numbers of days the subjects actually bled after the end of the second treatment cycle
Time frame: End of the second cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After First Treatment Cycle
The number of days between the first cycle of treatment and the withdrawal bleeding.
Time frame: End of the first cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After Second Treatment Cycle
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The number of days between the second cycle of treatment and the withdrawal bleeding
Time frame: End of the second cycle of treatment (cycle=28 days)