Trials / Completed
CompletedNCT02921763
A Survey on Efficacy and Safety in Patients With Endometriosis
Duphaston® Tablets 5 mg - A Survey on Efficacy and Safety in Patients With Endometriosis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Mylan Inc. · Industry
- Sex
- Female
- Age
- 20 Years – 49 Years
- Healthy volunteers
- Not accepted
Summary
This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients with endometriosis under actual condition of its use and to obtain data for effectively and safely utilizing this drug.
Detailed description
In Japan, Duphaston® Tablets have appeared in 1965 for the treatment of endometriosis and been used at some medical institutions. However, after releasing of danazol in the early 1980's and gonadotropin-releasing hormone (GnRH) agonists in the late 1980's, pseudomenopause therapy became mainstream because of its high efficacy. However, pseudopregnancy therapy was recognized again due to adverse reactions associated with pseudomenopause therapy. After 2000, low-dose estrogen/progestin (LEP) combination drugs (as LEP products, ethinylestradiol/norethisterone combination drug and ethinylestradiol/drospirenone combination drug) and dienogest have been utilized as drugs that are safer and can be administered for a long time. In recent years, Duphaston® Tablets are increasing recognized again from the viewpoints of its efficacy and safety because the drug has no effect to inhibit ovulation or effect on basal body temperature, a diagnosis of ovulation and other conditions may be made by following up basal body temperature, and pregnancy may be achieved even during treatment with Duphaston. As previously mentioned, Duphaston® Tablets are an old drug, and there are only few clinical data from Japanese patients; thus, its latest clinical efficacy and safety data are being demanded again mainly by obstetrician-gynecologists.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dydrogesterone |
Timeline
- Start date
- 2016-08-23
- Primary completion
- 2017-09-21
- Completion
- 2017-10-13
- First posted
- 2016-10-03
- Last updated
- 2022-07-06
- Results posted
- 2022-06-13
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02921763. Inclusion in this directory is not an endorsement.