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This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR-2021a | Drug | 1 capsule daily for 10 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. | Throughout study period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset, duration, and severity of withdrawal bleeding. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duramed Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Duramed Investigational Site |
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| 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 |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Duramed Investigational Site | Tucson | Arizona | 85712 | United States |
| Duramed Investigational Site | Carmichael | California | 95608 | United States |
| Duramed Investigational Site | San Diego | California | 92123 | United States |
| Duramed Investigational Site | San Diego | California | 92130 | United States |
| Duramed Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Duramed Investigational Site | Pueblo | Colorado | 81001 | United States |
| Duramed Investigational Site | Gainesville | Florida | 32605 | United States |
| Duramed Investigational Site | Leesburg | Florida | 34748 | United States |
| Duramed Investigational Site | Miami | Florida | 33143 | United States |
| Duramed Investigational Site | Atlanta | Georgia | 30328 | United States |
| Duramed Investigational Ste | Dawsonville | Georgia | 30534 | United States |
| Duramed Investigational Site | Douglasville | Georgia | 30134 | United States |
| Duramed Investigational Site | Laurel | Maryland | 20707 | United States |
| Duramed Investigational Site | St Louis | Missouri | 63110 | United States |
| Duramed Investigational Site | Alliance | Nebraska | 69301 | United States |
| Duramed Investigational Site | Lawrenceville | New Jersey | 08648 | United States |
| Duramed Investigational Site | Medford | Oregon | 97505 | United States |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | United States |
| Duramed Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| Duramed Investigational Site | Columbia | South Carolina | 29201 | United States |
| Duramed Investigational Site | Memphis | Tennessee | 38120 | United States |
| Duramed Investigational Site | Dallas | Texas | 75390 | United States |
| Duramed Investigational Site | Houston | Texas | 77030 | United States |
| Duramed Investigational Site | Houston | Texas | 77074 | United States |
| Duramed Investigational Site | Newport News | Virginia | 23602 | United States |
| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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