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Also known as Micronized progesterone
DR-2021a · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DR-2021a | DRUG | 1 capsule daily for 10 days |
| DR-2021b | DRUG | 1 capsule daily for 10 days |
| DR-2021c | DRUG | 1 capsule daily for 10 days |
| DR-2021d | DRUG | 1 capsule daily for 10 days |
| DR-2021e | DRUG | 1 capsule daily for 10 days |
| Placebo | OTHER | 1 matching placebo capsule for 10 days |
Inclusion Criteria: * Not pregnant * Secondary amenorrhea or oligomenorrhea of at least 50 days duration * Not currently on any hormonal medication * Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom) Exclusion Criteria: * Use an inject...
DR-2021a is being developed for the treatment of amenorrhea, specifically secondary amenorrhea in women. It is an investigational small molecule in Phase 2 clinical development. It has not been approved for any indication.
DR-2021a is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the Phase 2 trial evaluating the drug in women with secondary amenorrhea.
DR-2021a is in Phase 2 clinical development. The single Phase 2 trial has been completed, and no active trials are currently listed. It is an investigational drug and has not been approved by the FDA.
DR-2021a has been studied in one completed Phase 2 trial, NCT00196391, titled A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea. The trial enrolled 180 female participants aged 18 years and older in the United States.
The Phase 2 trial of DR-2021a, NCT00196391, was a randomized, double-blind, placebo-controlled study. It enrolled 180 women with secondary amenorrhea across sites in the United States. Participants were 18 years of age or older, and healthy volunteers were not included.