Proellex (telapristone) / AbbVie  >>  Phase 1
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9 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Proellex (telapristone) / AbbVie
NCT01067807: Proellex Pharmacokinetics Bridging Study

Completed
1
21
US
25 mg Proellex, CDB-4124, Telapristone acetate, 50 mg Proellex
Repros Therapeutics Inc.
Healthy
07/07
07/07
NCT00620503: Proellex® Pharmacokinetic Bridging Study II

Completed
1
12
US
Proellex 25 mg formulation A, Telapristonee acetate, Proellex 25 mg formulation B, Telapristone acetate
Repros Therapeutics Inc.
Healthy
04/08
04/08
NCT00619385: A Safety and Pharmacokinetic Study of Proellex®

Completed
1
25
US
Proellex, Telapristone acetate
Repros Therapeutics Inc.
Healthy
09/08
10/08
NCT00741468: Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

Completed
1
18
US
Proellex, Telapristone acetate, CYP1A2 probe, Caffeine (200 mg), CYP2C9 probe, Tolbutamide (250 mg), CYP2C19 probe, Omeprazole (20 mg), CYP2D6 probe, Dextromethorphan (30 mg), CYP3A4 probe, Midazolam (2mg)
Repros Therapeutics Inc.
Drug Interactions
09/08
10/08
NCT00749879: Crossover Study of the Safety and PK Properties of Proellex®

Completed
1
17
US
Proellex, Telapristone acetate
Repros Therapeutics Inc.
Pharmacokinetics
10/08
10/08
NCT00741273: Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

Completed
1
16
US
Proellex, Telapristone acetate
Repros Therapeutics Inc.
Impaired Liver Function
05/09
06/09
NCT00881062: Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females

Completed
1
6
US
Proellex, Telapristone acetate
Repros Therapeutics Inc.
ABSORPTION, METABOLISM, EXCRETION
05/09
06/09
NCT00881608: Study to Evaluate Menses Induction in Women Administered Proellex

Terminated
1
11
US
Placebo, Dummy, Proellex, Telapristone acetate
Repros Therapeutics Inc.
Amenorrhea
08/09
08/09
NCT02141061: Comparison of Two Formulations of Proellex for Oral Administration

Completed
1
12
US
Telapristone Acetate, Proellex 12 mg Formulation A, Proellex, Telapristone Acetate, Proellex 12 mg Formulation B
Repros Therapeutics Inc.
Healthy
06/14
06/14

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