WHO ICTRP trial
A clinical trial to see if LPRI-424 is safe and works for Polycystic Ovary…
ISRCTN76318215 · International Standard Randomised Controlled Trial Number (ISRCTN) · Recruiting
Key facts
| Trial ID | ISRCTN76318215 |
|---|---|
| Public title | A clinical trial to see if LPRI-424 is safe and works for Polycystic Ovary Syndrome compared to a placebo for 9 months |
| Scientific title | A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-424 (dienogest 2.00 mg / ethinyl estradiol 0.02 mg) in the treatment of polycystic ovary syndrome (PCOS) versus placebo during 9 cycles |
| Primary sponsor | Chemo Research S.L. |
| Registry | International Standard Randomised Controlled Trial Number (ISRCTN) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase III |
| Countries | Czech Republic;Hungary;Lithuania;Poland;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| Conditions | Excess of body hair in women with polycystic ovarian syndrome (PCOS) Nutritional, Metabolic, Endocrine Hirsutism related to Polycystic Ovarian Syndrome |
| Interventions | Duration of treatment: 9 sequential cycles of 28 days (252 days in total) Dose and mode of administration: a) Test product: LPRI-424 tablets (dienogest [DNG] 2 mg / ethinyl estradiol [EE] 0.02 mg), film-coated tablets, oral administration… |
| Registration date | Sep 14, 2022 |
| Target size | 367 |
| Secondary IDs | 2021-002178-17;Nil known;LPRI-424/304, IRAS 1006162, CPMS 47924 |
| Registry page | isrctn.com |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: