17 completed. 17 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 17 | Completed 17 |
| Phase 2 | 2 | Completed 2 |
Follow Dutasteride: new trials by email Literature Review of Dutasteride trials Research Report on Dutasteride
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 |
|---|---|---|---|---|---|---|
| Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil Dutasteride 0.5 mg, Tadalafil 5 mg, YY-201 - Benign Prostatic Hyperplasia | Phase 1 | Completed | Yuyu Pharma, Inc. | 36 | 2017-03-27 | 2017-11-24 |
| A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects Tadalafil, Dutasteride - Benign Prostate Hyperplasia | Phase 1 | Completed | Yuyu Pharma, Inc. | 28 | 2016-05-01 | 2017-04-04 |
| Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects FDC capsule of dutasteride and tamsulosin, Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 56 | 2015-07-30 | 2018-06-19 |
| Safety and Pharmacokinetic Characteristics of DKF-313 DKF-313, AVODART, CIALIS - Benign Prostate Hyperplasia, Healthy | Phase 1 | Completed | Dongkook Pharmaceutical Co., Ltd. | 54 | 2015-01-01 | 2021-07-06 |
| This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Dutasteride and Tamsulosin - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 24 | 2013-10-25 | 2018-06-19 |
| Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers GI198745 0.1 mg, GI198745 0.5 mg - Alopecia | Phase 1 | Completed | GlaxoSmithKline | 36 | 2013-09-23 | 2018-06-19 |
| Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride Tadalafil, Dutasteride - Benign Prostate Hyperplasia | Phase 1 | Completed | Dongkook Pharmaceutical Co., Ltd. | 47 | 2013-09-01 | 2015-01-26 |
| Bioequivalence - Duodart Against Avodart & Omnic dutasteride/tamsulosin, dutasteride, tamsulosin - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 35 | 2012-08-23 | 2017-06-20 |
| A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state) - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 63 | 2011-11-06 | 2018-06-19 |
| Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. Dutasteride (0.5mg), FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg), Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl) - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 27 | 2011-06-30 | 2018-06-19 |
| Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects dutasteride - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 35 | 2011-05-12 | 2018-06-19 |
| ITT4 Intratesticular Hormonal Milieu in Man (ITT4) Acyline, Testosterone gel, ketoconazole 400 - Healthy Males | Phase 1 / Phase 2 | Completed | University of Washington | 46 | 2011-01-01 | 2014-03-31 |
| A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg) - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 86 | 2010-09-10 | 2017-06-12 |
| A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State. GI198745 - Prostatic Hyperplasia | Phase 1 | Completed | GlaxoSmithKline | 24 | 2008-02-26 | 2017-08-04 |
| Oral Androgens in Man-4: (Short Title: Oral T-4) Testosterone Enanthate, Dutasteride, placebo sesame oil - Contraception | Phase 1 / Phase 2 | Completed | University of Washington | 20 | 2006-11-01 | 2008-09-22 |
| Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men Placebo, Testosterone, Anastrazole - Aging | Phase 1 | Completed | Mayo Clinic | 80 | 2005-12-01 | 2012-07-31 |
| Dutasteride to Treat Women With Menstrually Related Mood Disorders Dutasteride, Placebo oral capsule - Premenstrual Syndrome, PMS | Phase 1 | Completed | National Institute of Mental Health (NIMH) | 34 | 2004-03-31 | 2019-12-17 |
Prostatic Hyperplasia (12) · Alopecia (1) · Depression (1) · Premenstrual Syndrome (1)
GlaxoSmithKline (9) · Dongkook Pharmaceutical Co., Ltd. (2) · University of Washington (2) · Yuyu Pharma, Inc. (2) · Mayo Clinic (1) · National Institute of Mental Health (NIMH) (1)
United States (7) · Australia (4) · South Korea (3) · China (1) · Russia (1)
Hyeong-Seok Lim, M.D.,Ph.D. (1) · Johannes D. Veldhuis, M.D. (1) · John K Amory, MD, MPH (1) · Mara Y Roth, MD (1) · Min-Gul Kim, M.D. (1) · Pedro E Martinez, M.D. (1)
PMID 18046048, PMID 23348398, PMID 27536459, PMID 28800206
K23HD045386 (1), U54HD012629 (1), U54HD042454 (1)