Overview
A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit ovulation.
Background
A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit ovulation.
Indication
Used to treat irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency. Also used to prevent natural abortion in patients who have a history of habitual abortions.
Associated Conditions
- Infertility
- Menstrual Distress (Dysmenorrhea)
- Premenstrual Syndrome (PMS)
- Recurrent Miscarriages
- Spontaneous Abortions
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/30 | N/A | Not yet recruiting | |||
2025/03/11 | Phase 3 | Completed | Kasr El Aini Hospital | ||
2024/08/19 | Phase 2 | Completed | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2024/04/22 | Not Applicable | Recruiting | Mỹ Đức Hospital | ||
2023/08/02 | Phase 3 | Recruiting | |||
2023/07/19 | Phase 2 | Not yet recruiting | |||
2023/03/14 | Not Applicable | Completed | |||
2023/03/07 | Phase 2 | Recruiting | El Shatby University Hospital for Obstetrics and Gynecology | ||
2023/03/02 | Not Applicable | Recruiting | |||
2022/10/13 | N/A | Completed | Clinica de la Mujer Medicina Reproductiva, Chile |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUPHASTON TABLET 10 mg (Film-coated) | SIN11255P | TABLET, FILM COATED | 10 mg | 1/10/2000 | |
| FEMOSTON 2/10 TABLET | SIN09530P | TABLET, FILM COATED | 10 mg | 11/11/1997 | |
| FEMOSTON 1/10 TABLET | SIN11896P | TABLET, FILM COATED | 10 mg | 4/24/2002 | |
| FEMOSTON CONTI 1/5 TABLET | SIN12121P | TABLET, FILM COATED | 5 mg | 11/13/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dydrogesterone Tablets | 国药准字H20243163 | 化学药品 | 片剂 | 2/6/2024 | |
| Dydrogesterone Tablets | 国药准字H20254052 | 化学药品 | 片剂 | 4/30/2025 | |
| Dydrogesterone Tablets | 国药准字H20233769 | 化学药品 | 片剂 | 6/21/2023 | |
| Dydrogesterone Tablets | 国药准字H20244872 | 化学药品 | 片剂 | 9/10/2024 | |
| Dydrogesterone Tablets | 国药准字HJ20170221 | 化学药品 | 片剂 | 5/8/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FEMOSTON 2/10 estradiol 2mg and estradiol 2mg with Dydrogesterone 10mg tablet blister pack (CP) | 75889 | Medicine | A | 9/8/2000 | |
| FEMOSTON-CONTI tablet blister pack | 78654 | Medicine | A | 5/30/2001 | |
| FEMOSTON 1/10 estradiol 1mg and estradiol 1mg with dydrogesterone 10mg tablet blister pack | 219882 | Medicine | A | 5/8/2014 |