Product Description
Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis. Danazol is an androgenic steroid that is effective in treating the signs and symptoms of endometriosis, but its use is limited by adverse effects on lipid metabolism and by weight gain, edema, acne, vaginal dryness, hot flushes, oily skin, hirsutism, liver toxicity, and breast atrophy (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3140813/)
Mechanisms of Action: PR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Bayer
Company Location:
Company CEO: Werner Baumann
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Contraception|Hirsutism
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2021-002178-17 |
2021-002178-17 | P3 |
Completed |
Hirsutism |
2023-12-05 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT03945513 |
LPRI424/303 | P3 |
Completed |
Contraception |
2023-06-30 |
17% |
2023-11-15 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
