Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| progenta 12.5 mg | Experimental | Progenta (CDB-4124) 12.5 mg capsule |
|
| progenta 25 mg | Experimental | Progenta (CDB-4124) 25 mg capsule |
|
| progenta 50 mg | Experimental | Progenta (CDB-4124) 50 mg capsule |
|
| Lucron Depot | Active Comparator | Lucron Depot, Leuprolide acetate for depot suspension |
|
| placebo | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progenta | Drug | 12.5 mg, administered as a once daily oral dose for 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata. | 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald Wiehle, PhD | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University /MTZ Clinical Research Sp.zo.o. | Warsaw | 02-106 | Poland |
Not provided
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C461063 | telapristone acetate |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Progenta | Drug | 25 mg, administered as a once daily oral dose for 90 days. |
|
|
| Progenta | Drug | 50 mg, administered as a once daily oral dose for 90 days. |
|
|
| Lucron Depot | Drug | 3.75 mg IM monthly |
|
|
| Placebo | Drug | Administered as a once daily oral dose for 90 days. |
|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |