WHO ICTRP trial
A randomized, double-blind, placebo-controlled, multicentre study to evaluate…
EUCTR2023-000224-10-PL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2023-000224-10-PL |
|---|---|
| Public title | A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women. |
| Scientific title | A randomized, double-blind, placebo-controlled, multicentre study to evaluate the effect of a 12-week dose of 35 mg DHEA on quality of life in menopausal women. - DHEA/EPH/02/2022 |
| Primary sponsor | The Pharmaceutical Company LEK-AM Sp. Zo.o. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Poland |
| Conditions | Menopause;Therapeutic area: Health Care [N] - Population Characteristics [N01] |
| Interventions | Trade Name: Biosteron 10 mg, Biosteron 25 mg Product Name: DHEA Product Code: PR1-888-2022; PR2-888-2022 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use |
| Registration date | Dec 4, 2023 |
| Target size | 100 |
| Secondary IDs | PBKV.5zdnia03.08.2022 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: