Adults 18 to 47, female only, with Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants in Amenorrhea at the End of Treatment Course 1Primary· At the end of 18-weeks Treatment Course 1
Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.
Group
Value
95% CI
Placebo
0.0
Telapristone Acetate 6 mg
53.8
Telapristone Acetate 12 mg
46.7
Percentage of Participants in Amenorrhea at the End of Treatment Course 2Secondary· At the end of 18-weeks Treatment Course 2
Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score \>1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.
Group
Value
95% CI
Placebo
7.1
Telapristone Acetate 6 mg
46.2
Telapristone Acetate 12 mg
46.7
Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2Secondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-1.21
± 100.850
Telapristone Acetate 6 mg
-55.43
± 87.522
Telapristone Acetate 12 mg
-43.85
± 82.634
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-43.52
± 37.967
Telapristone Acetate 6 mg
-91.02
± 18.367
Telapristone Acetate 12 mg
-77.42
± 34.762
Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-33.54
± 30.981
Telapristone Acetate 6 mg
-49.68
± 37.927
Telapristone Acetate 12 mg
-42.27
± 45.842
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-31.11
± 33.577
Telapristone Acetate 6 mg
-43.69
± 35.919
Telapristone Acetate 12 mg
-37.98
± 46.287
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-37.38
± 30.153
Telapristone Acetate 6 mg
-26.90
± 26.126
Telapristone Acetate 12 mg
-14.66
± 41.842
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-19.58
± 27.672
Telapristone Acetate 6 mg
-52.50
± 33.811
Telapristone Acetate 12 mg
-53.75
± 28.052
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-21.00
± 30.074
Telapristone Acetate 6 mg
-55.00
± 34.319
Telapristone Acetate 12 mg
-60.50
± 27.330
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-31.67
± 41.003
Telapristone Acetate 6 mg
-23.89
± 31.798
Telapristone Acetate 12 mg
-22.22
± 26.471
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-34.03
± 28.431
Telapristone Acetate 6 mg
-49.03
± 36.205
Telapristone Acetate 12 mg
-21.81
± 108.137
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-30.67
± 26.646
Telapristone Acetate 6 mg
-43.83
± 40.484
Telapristone Acetate 12 mg
-45.00
± 57.542
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-45.00
± 29.686
Telapristone Acetate 6 mg
6.85
± 47.232
Telapristone Acetate 12 mg
2.78
± 116.916
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-16.39
± 26.178
Telapristone Acetate 6 mg
-26.81
± 37.176
Telapristone Acetate 12 mg
21.94
± 109.882
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
38.67
± 135.664
Telapristone Acetate 6 mg
-19.33
± 55.729
Telapristone Acetate 12 mg
-21.67
± 48.305
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
3.70
± 62.086
Telapristone Acetate 6 mg
14.44
± 37.118
Telapristone Acetate 12 mg
20.00
± 45.826
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-29.31
± 25.785
Telapristone Acetate 6 mg
-19.44
± 65.452
Telapristone Acetate 12 mg
65.28
± 136.090
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
10.17
± 45.443
Telapristone Acetate 6 mg
-40.50
± 35.677
Telapristone Acetate 12 mg
51.67
± 165.216
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
12.22
± 84.967
Telapristone Acetate 6 mg
-17.41
± 38.838
Telapristone Acetate 12 mg
97.22
± 120.185
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-33.61
± 36.054
Telapristone Acetate 6 mg
-41.11
± 30.939
Telapristone Acetate 12 mg
-53.33
± 27.220
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-33.83
± 29.419
Telapristone Acetate 6 mg
-36.83
± 36.847
Telapristone Acetate 12 mg
-10.67
± 57.811
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-27.22
± 42.76
Telapristone Acetate 6 mg
-7.04
± 49.137
Telapristone Acetate 12 mg
0.37
± 66.378
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-19.72
± 32.943
Telapristone Acetate 6 mg
-25.97
± 24.365
Telapristone Acetate 12 mg
-40.28
± 26.235
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-30.83
± 29.400
Telapristone Acetate 6 mg
-27.50
± 32.272
Telapristone Acetate 12 mg
-25.67
± 50.511
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-17.59
± 35.080
Telapristone Acetate 6 mg
-8.15
± 35.711
Telapristone Acetate 12 mg
-17.41
± 35.080
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent nighttime urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-30.83
± 26.443
Telapristone Acetate 6 mg
-29.03
± 32.539
Telapristone Acetate 12 mg
-30.69
± 41.209
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-31.83
± 29.819
Telapristone Acetate 6 mg
-45.17
± 24.999
Telapristone Acetate 12 mg
-7.67
± 59.277
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-36.30
± 24.463
Telapristone Acetate 6 mg
-33.15
± 20.008
Telapristone Acetate 12 mg
-27.59
± 39.678
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up VisitSecondary· Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Percentage Change from BL: Course 1
Group
Value
95% CI
Placebo
-30.42
± 27.174
Telapristone Acetate 6 mg
-40.69
± 29.759
Telapristone Acetate 12 mg
-38.33
± 65.308
Percentage Change from BL: Course 2
Group
Value
95% CI
Placebo
-28.33
± 25.784
Telapristone Acetate 6 mg
-32.33
± 28.976
Telapristone Acetate 12 mg
-27.50
± 37.509
Percentage Change: Course 2, Week 24 Follow-up
Group
Value
95% CI
Placebo
-27.59
± 27.299
Telapristone Acetate 6 mg
-22.59
± 19.421
Telapristone Acetate 12 mg
-12.22
± 29.059
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 2/14 (14%)
Deaths: 0/14
Telapristone Acetate 6 mg
Serious: 2/13 (15%)
Deaths: 0/13
Telapristone Acetate 12 mg
Serious: 2/15 (13%)
Deaths: 0/15
Serious adverse events (6 terms)
Reaction
System
Placebo
Telapristone Acetate 6 mg
Telapristone Acetate 12 mg
Anaemia
Blood and lymphatic system disorders
—
—
—
Iron deficiency anaemia
Blood and lymphatic system disorders
—
—
—
Chest injury
Injury, poisoning and procedural complications
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02301897 — A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proel
· Phase 2
· completed
Other recruiting trials for Uterine Fibroids
Currently open trials in the same condition.
NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
· Phase 3
· recruiting
NCT07486622 — Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical St
· active not recruiting
NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
· Phase 3
· recruiting
NCT05448365 — Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
· NA
· recruiting
NCT04126824 — Effect of Addition of Steroids on Duration of Analgesia
· EARLY_PHASE1
· active not recruiting
Other Repros Therapeutics Inc. trials
Trials by the same sponsor.
NCT02811159 — An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women
· Phase 2
· terminated
NCT02651688 — A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metab
· Phase 2
· completed
NCT02301897 — A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proel
· Phase 2
· completed
NCT01984398 — Comparison of Two Formulations of Androxal
· Phase 1
· completed
NCT01728454 — Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptom
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Repros Therapeutics Inc.
Last refreshed: 25 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02323646.