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.
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
Research Report
A Comprehensive Clinical and Pharmacological Monograph on Dydrogesterone (DB00378)
I. Drug Identification and Physicochemical Profile
Dydrogesterone is a well-established synthetic progestogen that has been utilized in clinical practice for over six decades. Its enduring presence in gynecology and obstetrics is attributable to a unique molecular structure that confers a highly specific pharmacological profile, distinguishing it from both endogenous progesterone and other synthetic progestins. This section provides a definitive summary of its identity and core physicochemical characteristics, which are fundamental to understanding its biological activity and therapeutic utility.
A. Core Identification
Dydrogesterone is classified as a small molecule drug belonging to the therapeutic class of hormonal agents, specifically synthetic progestogens.[1] Its systematic classification and various identifiers are crucial for unambiguous reference in clinical, regulatory, and research contexts.
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FEMFASCON 1 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 83783 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| FEMOSTON 0,5 MG/2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 83801 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| FEMFASCON 2 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 83782 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.