Trials / Terminated
TerminatedNCT02811159
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 47 Years
- Healthy volunteers
- Not accepted
Summary
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.
Detailed description
This study will be for participants who had completed either ZPV-201 or ZPU-203.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telapristone acetate | Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI. |
Timeline
- Start date
- 2016-07-26
- Primary completion
- 2017-05-04
- Completion
- 2017-05-04
- First posted
- 2016-06-23
- Last updated
- 2019-06-27
- Results posted
- 2019-06-19
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02811159. Inclusion in this directory is not an endorsement.