To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Primary
· 6 months
Number of participants who experienced 1 or more adverse event.
| Group | Value | 95% CI |
|---|---|---|
| Proellex® | 16 |
Last reviewed · How we verify
NCT00958412
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Terminated
Phase 2
Results posted
Last updated 12 February 2019
What this trial tests
Phase 2 trial testing Proellex® in Endometriosis in 18 participants. Terminated before completion.
Timeline
28 February 2009
Primary endpoint
31 August 2009
31 August 2009
31 August 2009
Quick facts
| Lead sponsor | Repros Therapeutics Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 28 February 2009 |
| Primary completion | 31 August 2009 |
| Estimated completion | 31 August 2009 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Proellex®
Conditions studied
- Endometriosis — all drugs for Endometriosis →
Sponsor
Repros Therapeutics Inc. — full company profile →
Who can join
Adults 18 to 48, female only, with Endometriosis. 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.
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Proellex®
Serious: 0/18 (0%)
Deaths: —
Other adverse events (36 terms — click to expand)
| Reaction | System | Proellex® |
|---|---|---|
| Hot Flashes | Vascular disorders | — |
| Decrease in Bone mineral Density | Investigations | — |
| Decreased bone Mineral Density in the Lumbar Spine | Investigations | — |
| left ovarian complex cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Mood Swings | Nervous system disorders | — |
| Seasonal Allergies | Immune system disorders | — |
| 1.5 % decrease femur bone density | Investigations | — |
| abnormal labs | Investigations | — |
| cervical tenderness | Reproductive system and breast disorders | — |
| Crying | Nervous system disorders | — |
| Cystic Left Ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Decreased Libido | Reproductive system and breast disorders | — |
| Elevated ALT | Investigations | — |
| Elevated AST | Investigations | — |
| exacerbation migraine | Nervous system disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Influenza | Infections and infestations | — |
| Irregular Heart Beat | Cardiac disorders | — |
| joint pain | Musculoskeletal and connective tissue disorders | — |
| Left Cystic Ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Left hip bone mineral density decreased | Investigations | — |
| left lower quadrant pain | Gastrointestinal disorders | — |
| Lumbar Spine Bone Mineral Density Decreased | Investigations | — |
| Right lower quadrant abdomen pain | Gastrointestinal disorders | — |
| Right ovarian complex cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| right ovarian cyst 1.5cm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Right Paraovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| sinus infection | Infections and infestations | — |
| skin rash | Skin and subcutaneous tissue disorders | — |
| vaginal discharge | Reproductive system and breast disorders | — |
| verruca vulgaris | Infections and infestations | — |
| weight gain | Investigations | — |
| Yeast Infection | Infections and infestations | — |
| sexual desire loss | Reproductive system and breast disorders | — |
| insomnia | Psychiatric disorders | — |
| Anxiety | Psychiatric disorders | — |
Data from ClinicalTrials.gov NCT00958412 adverse events section.
Sponsor's own description
ZPE-201 Extension of treatment
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.
Islam MS, Afrin S, Jones SI, Segars J. · · 2020 · cited 97× · PMID 32365199 · DOI 10.1210/endrev/bnaa012 -
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004
Verify or expand the search:
- PubMed search for NCT00958412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Proellex®
Trials testing the same drug.
- NCT00958334 — Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 · Phase 2 · completed
Other recruiting trials for Endometriosis
Currently open trials in the same condition.
- NCT06559852 — The Impact of Yoga on Endometriosis-Related Pain · NA · recruiting
- NCT07393295 — Efficacy and Tolerability of TENS in Endometriosis-related Pain · NA · recruiting
- NCT07134023 — Educational Program for the Multidisciplinary Support of Patients With Endometriosis · NA · recruiting
- NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
- NCT06974773 — Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups · NA · 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
- NCT02323646 — Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids · Phase 2 · completed
- NCT01984398 — Comparison of Two Formulations of Androxal · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00958412 (US National Library of Medicine, public domain)
- 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: 12 February 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/NCT00958412.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing