Dysmenorrhea
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CLINICAL_TRIALS trial_result · 2010-10-04Clinical Trial Update: SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study [Phase 2, Phase 3]
Update on a Phase II/III trial evaluating the optimal drospirenone dose versus placebo for dysmenorrhea; results have been posted.
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CLINICAL_TRIALS trial_result · 2010-10-04Clinical Trial Update: A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen [NA]
A completed clinical trial comparing pain relief during dysmenorrhea between the Vipon Tampon and ibuprofen, with results posted in 2010.
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CLINICAL_TRIALS trial_result · 2010-10-01Clinical Trial Update: Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea [Phase 2, Phase 3]
This clinical trial update reports safety results for a combined oral contraceptive containing Ethinylestradiol and Drospirenone in dysmenor…
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CLINICAL_TRIALS trial_result · 2010-09-10Clinical Trial Update: Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea. [Phase 3]
This clinical trial update reports the completion of a Phase 3 long-term study assessing the efficacy and safety of a low-dose oral contrace…
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CLINICAL_TRIALS trial_result · 2010-09-08Clinical Trial Update: Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea [Phase 3]
A Phase 3 trial sponsored by Nobelpharma evaluated the efficacy and safety of a low-dose oral contraceptive pill for dysmenorrhea and has co…
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CLINICAL_TRIALS research · 2010-09-01Clinical Trial Update: Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
This clinical trial update reports on the prevalence of menstrual cycle–related pain among adolescents and young adults with dysmenorrhea an…
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FDA approval · 2010-08-12FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for Naproxen Sodium submitted by Bionpharma Inc.
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CLINICAL_TRIALS research · 2010-08-06Clinical Trial Update: Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation [Phase 4]
This clinical trial registry entry describes a Phase 4 study of a combined ethinyl estradiol and cyproterone acetate regimen for irregular m…
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FDA approval · 2010-07-06FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)
FDA approved a supplemental application for diclofenac sodium from Edenbridge Pharmaceuticals LLC under the ANDA program. This action consti…
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FDA approval · 2010-03-19FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited. This action authorizes changes to the approved …
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EMA withdrawal · 2010-02-03EMA Withdrawn: Bextra (valdecoxib) — Pharmacia - Pfizer EEIG
The EMA indicates Bextra (valdecoxib) has been withdrawn from the market by Pharmacia - Pfizer EEIG.
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CLINICAL_TRIALS trial_result · 2010-02-03Clinical Trial Update: Treatment of Primary Menstrual Pain With Kanion Capsule [Phase 2]
Phase 2 clinical trial of Kanion Capsule for the treatment of primary dysmenorrhea has completed. Sponsor: Lianyungang Kanion Group, Ltd.
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CLINICAL_TRIALS research · 2009-09-24Clinical Trial Update: A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea [Phase 3]
This update describes a Phase 3 study evaluating the efficacy and safety of the Healing Stone Navel Belt for primary dysmenorrhea, sponsored…
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CLINICAL_TRIALS trial_result · 2009-06-25Clinical Trial Update: VA111913 TS: First in Human Study [Phase 1]
This update reports the completion of the first-in-human Phase 1 study of VA111913 TS for dysmenorrhea conducted by Vantia Ltd.
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FDA approval · 2008-10-29FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)
FDA approved a supplemental application from Granules India Ltd for Naproxen (Naproxen sodium) granules. This adds a granulated dosage form …
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CLINICAL_TRIALS trial_result · 2008-08-25Clinical Trial Update: Logan Basic and Dysmenorrhea [Phase 2]
Phase 2 clinical trial sponsored by Logan College of Chiropractic investigating dysmenorrhea (menstrual distress). The current status of the…
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FDA approval · 2008-07-25FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)
The FDA has approved a supplemental application for naproxen filed by Zameer Pharmaceuticals LLC.
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FDA approval · 2008-06-20FDA Approved: JUNIOR STRENGTH ADVIL — Supplemental Application (Haleon US Holdings LLC)
FDA approves a supplemental application for JUNIOR STRENGTH ADVIL (ibuprofen) from Haleon US Holdings LLC.
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CLINICAL_TRIALS trial_result · 2008-01-25Clinical Trial Update: Vitamin K Injections for the Treatment of Painful Menstruation [Phase 1]
A Phase 1 clinical trial evaluating Vitamin K injections for the treatment of dysmenorrhea has completed.
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FDA approval · 2008-01-14FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Celebrex (celecoxib) submitted by Viatris Specialty LLC to update the product labeling under NDA…
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FDA approval · 2007-11-07FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…
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FDA approval · 2007-09-25FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…
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FDA approval · 2007-07-26FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…
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FDA approval · 2007-07-15FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)
The FDA approved Granules India Ltd's supplemental application for Naproxen (naproxen sodium). This action approves a generic naproxen sodiu…
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FDA approval · 2007-03-28FDA Approved: NAPROXEN — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's naproxen generic under an original ANDA, enabling market access for generic naproxen products.