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DR-2021 in Women With Secondary Amenorrhea
NCT00196391Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2005
- Primary completion
- Apr 2007
- Countries
- 1
- Sponsor
- Duramed Research
- Modality
- Small Molecules
- Drugs
- progesterone
- Conditions
- secondary amenorrhea
01
Overview
Phase 2, randomised, double-blind trial of progesterone in secondary amenorrhea (6 arms), sponsored by Duramed Research. Primary endpoint: Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. Started Sep 2005; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
DR-2021a
DR-2021 Dose A (1 capsule daily for 10 days)
DR-2021b
DR-2021 Dose B (1 capsule daily for 10 days)
DR-2021c
DR-2021 Dose C (1 capsule daily for 10 days)
DR-2021d
DR-2021 Dose D (1 capsule daily for 10 days)
DR-2021e
DR-2021 Dose E or Active Control (1 capsule daily for 10 days)
Placebo
Placebo capsule daily for 10 days
03
Who it enrols
Women with secondary amenorrhea or oligomenorrhea of at least 50 days duration, not pregnant, and not on hormonal medication.
04
Endpoints
Primary
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding
Secondary
Time to onset, duration, and severity of withdrawal bleeding
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