The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
662
One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).
One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)
The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.
Time frame: Up to one year
Number of Participants With Amenorrhea During Month 1 to 3 of Treatment
The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Time frame: Month 1 to Month 3
Number of Participants With Amenorrhea During Month 10 to 12 of Treatment
The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.
Time frame: Month 10 to Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Chandler, Arizona, United States
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San Diego, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Greenwood Village, Colorado, United States
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Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Boise, Idaho, United States
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Amite, Louisiana, United States
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Marrero, Louisiana, United States
...and 49 more locations