Trials / Completed
CompletedNCT03690765
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Observational Open-Label Multicenter Study of Real Clinical Practice to Evaluate the Effects of Hormonal Therapy With Oral Dydrogesterone for Treatment of Confirmed Endometriosis (ORCHIDEA)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 350 (actual)
- Sponsor
- Abbott · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
A non-interventional, observational program to assess the effects of dydrogesterone (Duphaston®) 6-months-administration in patients with confirmed endometriosis in a post-marketing setting in the Russian Federation
Detailed description
A non-interventional, observational program to assess the effects of oral dydrogesterone therapy in a post-marketing setting whether the effects are related to the regimen of dydrogesterone therapy. In this observational program, assuming that dydrogesterone plays a role in the treatment of endometriosis without suppression of ovulation, the goal is to observe the possible implications of such treatment in terms of treatment regimen and response pattern. In the study will be described effects of Duphaston® 6-months-administration in patients with confirmed endometriosis by assessing pain relief, quality of life, need of self-medication with analgesics, etc.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duphaston® (Dydrogesterone) | No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle. Description of routine practice only. |
| DRUG | Duphaston® (Dydrogesterone) | No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day continuously. Description of routine practice only. |
Timeline
- Start date
- 2018-09-27
- Primary completion
- 2019-11-10
- Completion
- 2020-05-29
- First posted
- 2018-10-01
- Last updated
- 2021-12-28
Locations
21 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT03690765. Inclusion in this directory is not an endorsement.