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Promestriene

Generic Name
Promestriene
Drug Type
Small Molecule
Chemical Formula
C22H32O2
CAS Number
39219-28-8
Unique Ingredient Identifier
GXM4PER6WZ

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

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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