dydrogesterone
Trade name: gynorest
Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, dydrogesterone is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis. Dydrogesterone works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus. 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. Dydrogesterone was first introduced to the market in 1961, and is currently approved in over 100 countries world-wide. Banned in the USA and wthdrawn from the UK, but still used in other countries. — NCATS
Clinical trial activity
71 trials · 59 clinical orgs · 1 marketing orgs
Earliest trial started Oct 1, 2002 (NCT00206557)
Timeline
Indications
Approved for
Studied for
- Abortion, Habitual · Phase 4
- Abortion, Induced · Phase 4
- Abortion, Spontaneous · Phase 4
- Abortion, Threatened · Phase 4
- Aneuploidy · Phase 3
- Delivery, Obstetric · Phase 3
- Dydrogesterone · Phase 4
- Embryo Transfer · Phase 4
- Endometrial Neoplasms · Phase 4
- Endometriosis · Phase 2
- Fertilization in Vitro · Phase 4
- Genital Diseases, Female · Phase 4
- Genital Diseases, Male · Phase 4
- Glioma · Phase 1
- Gonadotropin-Releasing Hormone · Phase 3
- Gynatresia · Phase 4
- Hormone Replacement Therapy · Phase 4
- Hormones · Phase 4
- Hormones, Hormone Substitutes, and Hormone Antagonists · Phase 4
- Hot Flashes · Phase 4
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Infertility, Male · Phase 4
- Insulin Resistance · Phase 4
- Leiomyoma · Phase 4
- Luteal Phase · Phase 4
- Menopause · Phase 4
- Obstetric Labor, Premature · Phase 4
- Oocytes · Phase 1
- Ovarian Diseases · Phase 3
- Pharmacokinetics · Phase 4
- Physiological Effects of Drugs · Phase 4
- Polycystic Ovary Syndrome · Phase 2/Phase 3
- Postmenopause · Phase 3
- Pregnancy · Phase 3
- Pregnancy Complications · Phase 4
- Pregnancy Rate · Phase 3
- Premature Birth · Phase 2/Phase 3
- Primary Ovarian Insufficiency · Phase 4
- Progesterone · Phase 4
- Progestins · Phase 4
- Prostheses and Implants · Phase 4
- Psychotic Disorders · Phase 2
- Reproduction · Phase 4
- Reproductive Techniques, Assisted · Phase 4
- Schizophrenia · Phase 2
- Sperm Injections, Intracytoplasmic · Early Phase 1
- Tendon Injuries · Phase 4
- Venous Thrombosis · Phase 4
Mechanism of action
- Progesterone receptorAGONIST
PGR agonist
Approval history
- approved—
Chemistry & pharmacology
SMILES
CC(=O)[C@H]1CC[C@H]2[C@@H]3C=CC4=CC(=O)CC[C@@]4(C)[C@@H]3CC[C@]12C- Mol. weight
- 312.4458 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaDydrogesterone ↗
- NCATS90I02KLE8K ↗
- ChEMBLCHEMBL1200853 ↗
Also known as
- 10alpha-isopregnenone
- 10alpha-isopregnenone
- 6-dehydro-retro-progesterone
- 6-dehydro-retro-progesterone
- (9β,10α)-pregna-4,6-diene-3,20-dione
- (9β,10α)-pregna-4,6-diene-3,20-dione
- 9β,10α-pregna-4,6-diene-3,20-dione
- 9β,10α-pregna-4,6-diene-3,20-dione
- delta(6)-retroprogesterone
- delta(6)-retroprogesterone
- delta(sup 6)-retroprogesterone
- delta(sup 6)-retroprogesterone
- didrogesterona
- didrogesterona
- didrogesterone
- didrogesterone
- dihydrogesterone
- dihydrogesterone
- duphaston
- duphaston
- duphaston-hrt
- dydrogesterona
- dydrogesterona
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogesterone
- dydrogestérone
- dydrogestérone
- dydrogesteronum
- dydrogesteronum
- gestatron
- gestatron
- gynorest
- gynorest
- gynorest
- hydrogesterone
- hydrogesterone
- hydrogesterone
- hydrogestrone
- hydrogestrone
- isopregnenone
- isopregnenone
- isopregnenone
- isopregnenone
- retro-6-dehydroprogesterone
- retro-6-dehydroprogesterone
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07242131 | N/A | Dec 1, 2025 | Ege University |
| NCT06546397 | Phase 1 | May 9, 2024 | Zhejiang University |
| NCT06378268 | N/A | Apr 24, 2024 | Ho Chi Minh City University of Medicine and Pharmacy, My Duc Phu Nhuan Hospital |
| NCT05951400 | Phase 2/Phase 3 (Phase 3) | Aug 20, 2023 | Beni Suef University |
| NCT06143696 | N/A | Aug 1, 2023 | Nanjing Medical University |
| NCT05972902 | Phase 3 | Jul 15, 2023 | Beni Suef University |
| NCT05847660 | N/A | Jun 1, 2023 | Fayoum University |
| NCT06358014 | N/A | May 12, 2023 | Capital Medical University |
| NCT05767086 | N/A | Mar 15, 2023 | Bezmialem University |
| NCT05751681 | N/A | Feb 20, 2023 | Zagazig University |
| NCT06868576 | Phase 3 | Jan 3, 2023 | Cairo University |
| NCT05758064 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2023 | Alexandria University, El Shatby University Hospital for Obstetrics and Gynecology |
| NCT05467852 | Phase 3 | Dec 10, 2022 | First People's Hospital of Foshan, Shantou University, Shenzhen University, Sun Yat-Sen University |
| NCT05521828 | N/A | Dec 1, 2022 | Free University of Brussels |
| NCT05542797 | Phase 4 | Oct 31, 2022 | Konya Meram State Hospital |
| NCT05226494 | Phase 1 | Jun 23, 2022 | NanoPharmaceuticals LLC, Yale University |
| NCT05300841 | Early Phase 1 (Phase 1) | May 1, 2022 | Sohag University |
| NCT05112692 | N/A | Nov 30, 2021 | Mansoura University |
| NCT05156814 | Phase 4 | Nov 29, 2021 | Government of Russia |
| NCT05021094 | Phase 4 | Oct 1, 2021 | Nantong University |
Organizations
Research & Development (59)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Capital Medical University | Academic/Hospital | 8 | 8 | 3 | 2013 |
| Fudan University | Academic/Hospital | 5 | 5 | 2 | 2016 |
| Abbott | For profit | 4 | 3 | 2 | 2003 |
| Chulalongkorn University | Academic/Hospital | 3 | 3 | 2 | 2014 |
| Free University of Brussels | Academic/Hospital | 3 | 3 | 2 | 2019 |
| Solvay | For profit | 3 | 3 | 2 | 2005 |
| The University of Hong Kong | Academic/Hospital | 3 | 3 | 1 | 2016 |
| Assiut University | Academic/Hospital | 2 | 2 | 2 | 2017 |
| Beni Suef University | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 2 | 2 | 1 | 2014 |
| El Shatby University Hospital for Obstetrics and Gynecology | Academic/Hospital | 2 | 2 | 1 | 2020 |
| My Duc Phu Nhuan Hospital | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Nanjing Medical University | Academic/Hospital | 2 | 2 | 1 | 2017 |
| Sun Yat-Sen University | Academic/Hospital | 2 | 1 | 2 | 2021 |
| Zagazig University | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Alexandria University | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Bangladesh Medical University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Bezmialem University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2023 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Solvay | For profit | NDA | Jun 1, 1962 |