55 completed, 6 terminated. 32 Phase 3, 11 Phase 2, 10 Phase 1, 3 Not applicable, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 32 | Completed 31, Terminated 1 |
| Phase 2 | 11 | Completed 8, Terminated 3 |
| Phase 1 | 10 | Completed 9, Terminated 1 |
| Not applicable | 3 | Completed 3 |
| Phase 4 | 2 | Completed 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy Estradiol Vaginal Capsule (EVC), Placebo - Vulvovaginal Atrophy, Menopause | Phase 2 | Completed | Warner Chilcott | 203 | 2016-02-15 | 2017-08-23 |
| Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia WC3055, Placebo - Benign Prostatic Hyperplasia | Phase 2 | Completed | Warner Chilcott | 796 | 2013-08-01 | 2015-06-29 |
| Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia WC3011 Estradiol Vaginal Cream, Vehicle - Vulvovaginal Atrophy | Phase 3 | Completed | Warner Chilcott | 550 | 2013-04-12 | 2022-05-09 |
| Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction WC3036-11F/Alprostadil in Vehicle 2.5%, WC3036-12F/Alprostadil in Vehicle 0.5%, WC3036-13P/Vehicle Only 0.5% - Erectile Dysfunction | Phase 2 | Terminated | Warner Chilcott | 16 | 2013-02-01 | 2014-08-12 |
| Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women Vehicle, WC3011 Estradiol Vaginal Cream - Vulvovaginal Atrophy | Phase 3 | Completed | Warner Chilcott | 576 | 2013-01-31 | 2022-05-09 |
| Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream) WC3011 Estradiol Vaginal Cream - Vulvovaginal Atrophy | Phase 3 | Completed | Warner Chilcott | 309 | 2011-10-20 | 2022-05-09 |
| Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women WC3011 Estradiol Vaginal Cream, Vehicle - Postmenopausal Vulvovaginal Atrophy | Phase 3 | Completed | Warner Chilcott | 722 | 2011-06-29 | 2022-05-09 |
| Effect of Udenafil on Spermatogenesis Placebo, Udenafil - Spermatogenesis, Erectile Dysfunction | Phase 1 | Completed | Warner Chilcott | 239 | 2010-09-01 | 2011-11-30 |
| Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin Doxycyline Hyclate tablet, Vibramycin (doxycyline hyclate) capsule - Urogential Chlamydia Trachomatis Infection | Phase 3 | Completed | Warner Chilcott | 495 | 2010-04-01 | 2012-01-27 |
| Effect of Assessing Risk for Osteoporosis on Physician and Patient Behaviors FRAX Assessment Tool - Osteoporosis, Osteopenia | Not applicable | Completed | Duquesne University | 90 | 2010-02-01 | 2012-04-06 |
| Treatment of Erectile Dysfunction - Long Term Safety and Efficacy Udenafil 50 mg, Udenafil 100 mg, Udenafil 150 mg - Erectile Dysfunction | Phase 3 | Completed | Warner Chilcott | 1027 | 2010-01-01 | 2015-04-20 |
| Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis Asacol 400 mg - Ulcerative Colitis | Phase 3 | Terminated | Warner Chilcott | 39 | 2009-10-01 | 2012-05-25 |
| Treatment of Erectile Dysfunction II Udenafil, Placebo - Erectile Dysfunction | Phase 3 | Completed | Warner Chilcott | 601 | 2009-09-01 | 2015-06-19 |
| Treatment of Erectile Dysfunction I Udenafil, Placebo - Erectile Dysfunction | Phase 3 | Completed | Warner Chilcott | 618 | 2009-09-01 | 2011-12-22 |
| Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure placebo, testosterone - Heart Failure | Phase 2 | Terminated | Warner Chilcott | 17 | 2009-07-01 | 2012-01-13 |
| Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women 150 mg, 75 mg, 100 mg - Postmenopausal Osteoporosis | Phase 2 | Completed | Warner Chilcott | 205 | 2009-05-01 | 2015-06-29 |
| Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food 35 mg risedronate DR tablet - Healthy | Phase 1 | Completed | Warner Chilcott | 101 | 2009-03-01 | 2011-10-12 |
| A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects risedronate DR (Phase III clinical supply), risedronate 35 mg DR (Commercial Tablet) - Osteoporosis | Phase 1 | Completed | Warner Chilcott | 538 | 2009-01-01 | 2011-10-12 |
| Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis Asacol 400 mg - Ulcerative Colitis | Phase 3 | Completed | Warner Chilcott | 83 | 2008-12-01 | 2012-04-05 |
| A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity Darifenacin - Neurogenic Detrusor Overactivity | Phase 2 | Terminated | Warner Chilcott | 35 | 2008-10-07 | 2022-06-09 |
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Osteoporosis (9) · Colitis, Ulcerative (8) · Sexual Dysfunctions, Psychological (7) · Erectile Dysfunction (5) · Osteoporosis, Postmenopausal (5) · Bone Diseases, Metabolic (3) · Acne Vulgaris (2) · Dyspareunia (2) · Chlamydia Infections (1) · Diverticulitis (1) · Fractures, Bone (1) · Headache (1) · Heart Failure (1) · Inflammatory Bowel Diseases (1) · Meningomyelocele (1)
Risedronic Acid (17) · Mesalamine (8) · Testosterone (4) · udenafil (4) · Doxycycline (3) · Ethinyl Estradiol (3) · Norethindrone Acetate (2) · Alendronate (1) · Anti-Bacterial Agents (1) · Capsules (1) · Control Groups (1) · Estradiol (1) · Estrogens, Conjugated (USP) (1) · Norethindrone (1) · Nutrition Assessment (1)
United States (55) · Canada (16) · Australia (11) · Poland (10) · Belgium (5) · Hungary (5) · Argentina (4) · Croatia (4) · France (4) · Spain (4) · United Kingdom (4) · Czechia (3) · Estonia (3) · Finland (3) · Germany (3)
Herman Ellman, MD (12) · Anna Chan, PharmD (4) · Johna Lucas, MD (4) · Chantell Wilson, PhD (3) · William S Aronstein, MD, PhD (3) · Ana Balske, MD, PhD (2) · Angelo Secci, MD (2) · Dietrich H Wenderoth, MD (2) · Piotr Krzeski, MD (2) · Vilma Sniukiene, MD (2) · Amy Sun, MD, PhD (1) · Ana M Balske, MD (1) · Ana M Balske, MD, PhD (1) · Angela X Qu, MD, MS (1) · Dietrich Wenderoth, MD (1)
PMID 21255059, PMID 21385195, PMID 18987368, PMID 20064514, PMID 21412137, PMID 21947137, PMID 22431798, PMID 22750403, PMID 23426454, PMID 23504379, PMID 23921878, PMID 23927913, PMID 24780062, PMID 25419597, PMID 26410176, PMID 26523214, PMID 29445831, PMID 32671846