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ASPEN-DIENOGEST is a brand name for Dienogest, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
and WARNINGS AND PRECAUTIONS, Hepatic). Dienogest has not been studied in patients with impaired liver function. Renal Insufficiency Dienogest has not been studied in patients with impaired renal function. However, no special risk for these patients is expected since dienogest is almost completely metabolized before excretion and the metabolites are pharmacologically inactive.
STORAGE AND STABILITY ASPEN-DIENOGEST should be stored in the original packaging between 15°C and 25°C. SPECIAL HANDLING INSTRUCTIONS There are no special handling instructions. DOSAGE FORMS, COMPOSITION AND PACKAGING ASPEN-DIENOGEST (dienogest) is available as white, round, biconvex film-coated tablets, embossed with “2” on one side.
Each tablet contains 2 mg dienogest and the following nonmedicinal ingredients: cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, maize starch, povidone K 30, sodium starch glycolate (Type A), talc and titanium dioxide.
ASPEN-DIENOGEST is available in blister packs of 28 tablets. 43 g / mol Structural formula: Physicochemical properties: White to off-white crystalline powder. Practically insoluble in water and neutral within the physiologically relevant pH range.
Melting range is 210°C to 218°C. Dienogest is a neutral molecule within pH 2-12. ) and Visanne® 2 mg tablets (Jenapharm GmbH & Co. KG, Germany) was conducted in healthy, non-smoking, post- menopausal female volunteers under fasting conditions.
) † Visanne® (dienogest) 2 mg tablets (Jenapharm GmbH & Co. KG, Germany) § Expressed as median (range) only € Expressed as arithmetic mean (CV %) only Study Demographics and Trial Design Three pivotal trials (Studies 307041, 307059, and 97085) evaluated the efficacy of dienogest in the management of pelvic pain associated with endometriosis using a visual analog scale (VAS) (0-100 mm).
Patients with a confirmed diagnosis of endometriosis assessed by laparoscopy or laparotomy prior to treatment were included. These studies included patients with all stages of disease severity based on the rAFS or rARSM (revised American Society for Reproductive Medicine) classification systems.
The placebo-controlled study (Study 307041) was a multicenter, double-blind, randomized trial designed to prove the superiority of dienogest compared to placebo. A total of 198 patients with endometriosis were treated over a period of 3 months.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8% and 26% of placebo patients) had moderate (stage III) and severe (stage IV) endometriosis, respectively. (14) An open-label extension to this placebo-controlled study included a total of 168 women to assess the long-term efficacy of continued dienogest treatment (Study 307059).
Patients previously treated with either placebo or dienogest in Study 307041 received dienogest for an additional 52 weeks. (15) Pelvic pain associated with endometriosis was also assessed in a 6-month noninferiority trial comparing dienogest and leuprorelin acetate in 252 patients with endometriosis (Study 97085).
5% and 15% of dienogest patients at baseline, respectively. (16) Table 5 – Summary of Pivotal Studies for the Management of Pelvic Pain Associated With Endometriosis With Dienogest 2 mg Report (Study) / Phase (Study Design) Primary Endpoint Treatment Regimen Treatment Duration No.
9 (18-46) ASPEN-Dienogest Product Monograph Page 22 of 41 Table 5 – Summary of Pivotal Studies for the Management of Pelvic Pain Associated With Endometriosis With Dienogest 2 mg Report (Study) / Phase (Study Design) Primary Endpoint Treatment Regimen Treatment Duration No.
of Patients (Full Analysis Set) Mean Age (Years) AU19 (97085) / phase 3 (Multicenter, open- label, randomized, active-controlled, parallel-group) Pelvic pain associated with endometriosis assessed by VAS Dienogest oral once daily 24 weeks […]