Overview
Promestriene (3-propyl ethyl, 17B-methyl estradiol) has been used in trials studying the prevention of Hypospadias. It is a synthetic estrogen analog, which is used in topical estrogen therapy. Promestriene’s potential for treating vaginal atrophy symptoms associated with aromatase inhibitor treatment would be precluded if its minimal absorption leads to estrogen-like effects on cell proliferation and estrogen-responsive gene expression. The concern with absorbed vaginal estrogens or estrogen analogs is that they activate occult sites of residual breast cancer or negate the tumor suppressive effects of aromatase inhibitor adjuvant therapy. Promestriene has been studied in phase IV of the clinical trial on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security in patients with vaginitis atrophic pelvic; organ prolapse and endometrial hyperplasia. It has been also studied in phase III of the clinical trial in the post-operative patients with hypospadias. In addition, promestriene was in phase IV of the clinical trial to study its treatment of patients with vaginosis, bacterial, but that studied was terminated.
Indication
临床适用于雌激素缺乏性阴道萎缩和产后、手术或理疗时子宫阴道及外阴愈合迟缓。
Associated Conditions
- Impaired Wound Healing
- Vulvo Vaginal Atrophy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/01/22 | Not Applicable | Completed | |||
2020/12/08 | Not Applicable | UNKNOWN | |||
2020/01/18 | Phase 3 | Completed | |||
2019/09/09 | Not Applicable | Active, not recruiting | Federal University of São Paulo | ||
2017/01/26 | Phase 4 | Completed | |||
2011/06/10 | Phase 3 | Completed |
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 |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Promestriene Cream | 国药准字H20046587 | 化学药品 | 乳膏剂 | 12/18/2020 | |
Promestriene Cream | 国药准字H20059606 | 化学药品 | 乳膏剂 | 6/12/2020 | |
Promestriene Vaginal Capsules | 国药准字H11022463 | 化学药品 | N/A | 7/19/2022 | |
Promestriene Vaginal Capsules | 国药准字H11020281 | 化学药品 | N/A | 1/21/2022 | |
Promestriene Vaginal Capsules | 国药准字H32021411 | 化学药品 | 原料药 | 9/2/2020 | |
Promestriene Vaginal Capsules | 国药准字H20045762 | 化学药品 | 胶囊剂 | 4/15/2020 | |
Promestriene Vaginal Soft Capsules | 国药准字H20059607 | 化学药品 | 胶囊剂(软胶囊) | 6/12/2020 |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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