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EndometriosisNCT03690765

Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis

An observational study of Endometriosis, run by Abbott at 21 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Duphaston® (Dydrogesterone)
How many people
350 participants
Where
21 sitesRussia
Study dates
27 Sep 2018to 29 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®

Who may be able to join

  • Female, aged ≥ 18 years and ≤ 45 years.
  • Complaints on chronic pelvic pain with or without dysmenorrhea assessed by 11-items NRS.
  • External genital endometriosis confirmed by laparoscopy.
  • Existing pelvic (vaginal) ultrasound data not earlier than 2 months before inclusion in the study.
  • Prescribed treatment with Duphaston® 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 or continuously.
  • No hormonal treatment in 2 cycles before enrollment.
  • Signed Patient Authorization for Use/Disclosure of Data.

Who cannot join

  • Any co-existing disease(s) needing chronic drug therapy (e.g. Crohn's disease, diabetes etc); Severe concomitant medical illness.
  • Severe other genital pathology excluding endometriosis (e.g. Multiple/severe myoma; adenomyosis, inflammatory diseases, etc.).
  • Routine consumption of analgesics other than for the pain of endometriosis.
  • Patients receiving hormonal contraceptives in last 2 cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives etc.).
  • Ongoing pregnancy.
  • Menopause or premature ovarian failure.
Show all 11Show fewer
  • Contraindications to dydrogesterone treatment listed in the locally approved label (Instructions for the medical use of Duphaston®).
  • Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions and special warnings listed in the locally approved label (Instructions for the medical use of Duphaston®).
  • Abnormal results of pap smear test.
  • Other conditions that made the patients participation impossible (based on the investigator decision).
  • Fertility treatments using assisted reproductive technology.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Russia21 sites

  • South Ural State Medical University, Department of Obstetrics and Gynecology

    Chelyabinsk, 454076

  • Engels Perinatal Center

    Engel's, 413116

  • City Hospital №11

    Kazan', 420127

  • Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center

    Kemerovo, 650066

  • Kuban State Medical University. Regional Clinical Hospital №2

    Krasnodar, 350012

  • Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood

    Krasnoyarsk, 660022

  • Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic

    Krasnoyarsk, 660049

  • RZD Central Clinical Hospital № 6

    Moscow, 109388

  • Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

    Moscow, 117997

  • Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

    Moscow

  • Clinical Center for Family Health and Reproduction of the Novosibirsk Region

    Novosibirsk, 630136

  • Rostov State Medical University, Research institute of obstetrics and pediatrics

    Rostov-on-Don, 344022

  • Pavlov First St. Petersburg State Medical University

    Saint Petersburg, 197022

  • Ott Research Institute of Obstetrics, Gynecology and Reproductology

    Saint Petersburg, 199034

  • Stavropol State Medical University

    Stavropol, 355017

  • State Hospital Perinatal Center

    Tyumen, 625002

  • Bashkir State Medical University

    Ufa, 450092

  • Semashko Nizhny Novgorod Regional Clinical Hospital

    Velikiy Novgorod, 603126

  • Clinic "New Medical Technologies"

    Voronezh, 394024

  • Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center

    Voronezh, 394066

  • FOTEK Medical Holding LLC, Women's Clinic

    Yekaterinburg, 620137

Other trials in Russia

About this study

Official title: 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)

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

Read the 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
Endometriosis
Being tested
Duphaston® (Dydrogesterone)
Keywords
endometriosis, dydrogesterone, Duphaston®, progestogens, pelvic pain
Medical subject headings
Endometriosis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duphaston® (Dydrogesterone)Drug

    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.

  • Duphaston® (Dydrogesterone)Drug

    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.

Study groups in NCT03690765
Study groupRoleWhat they receive
Endometriosis/DydrogesteroneFemales aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®
Receives: Drug: Duphaston® (Dydrogesterone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in chronic pelvic pain intensity

    The changes in chronic pelvic pain intensity assessed by 11-items Numerous Rating Scale (NRS) at the end of observation (Visit 3) versus Baseline (Visit 1) in the prolonged cyclic regime and the continuous regime of Duphaston in patients with endometriosis. The 11-items Numerous Rating Scale (NRS) contains the range from 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst pain'. Patients are asked to point the average pain intensity throughout the last month. The negative change corresponds to better result.

    Measured: 6 months

Secondary outcomes (6)

  1. Change in Quality of Life

    Changes in Quality of Life assessed by Short Form-20 (SF-20) at the end of observation (Visit3) versus Baseline (Visit1) in patients with endometriosis. The Short Form-20 (Copyright © the RAND Corporation) consists of 20 questions grouped into two parameters: psychological and physical components of health. The indicators of each scale are compiled in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the chosen parameter.

    Measured: 3 months, 6 months

  2. Change in chronic pelvic pain intensity

    Change in Patient-reported severity of chronic pelvic pain assessed by 11-items NRS after 3-months treatment (Visit2) and after 6-months treatment (Visit3) versus Baseline (Visit1) in patients with endometriosis

    Measured: 3 months, 6 months

  3. Cycles' duration

    Description of the cycles' duration during 6-months treatment by Duphaston® in patients with endometriosis

    Measured: 6 months

  4. Change in dysmenorrhea

    Description of the changes in dysmenorrhea assessed by 11-items NRS after 3-months treatment (Visit2) and after 6-months treatment (Visit3) versus Baseline (Visit1) in patients with endometriosis. The 11-items Numerous Rating Scale (NRS) contains the range from 0 to 10, where 0 represents 'No symptoms' and 10 represents 'the Worst trouble'. Patients are asked to point the average intensity of dysmenorrhea symptoms (cyclic pelvic pain, mood disorders, gastro-intestinal symptoms etc.) during the last menses period. The negative change corresponds to better result.

    Measured: 3 months, 6 months

  5. Analgesics using

    A number of days per each cycle (1-6) when analgesics were self-administered

    Measured: 6 months

  6. Sexual wellbeing

    Description of the change in sexual wellbeing assessed by A Quality Assessment of Patient-Reported Outcome Measures for Sexual Wellbeing (5-points Likert scale) at the end of observation (Visit3) versus Baseline (Visit1). A Quality Assessment of Patient-Reported Outcome Measures for Sexual Wellbeing by 5-points Likert scale proposes patients to rate themselves on a 5-point scale as being 'very satisfied, satisfied, ordinarily, rather not satisfied, not satisfied'. The number (and proportion) of patients in each category will be presented.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start27 Sep 2018
  3. Primary completion10 Nov 2019
  4. Study completion29 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690765
Sponsor's protocol ID
DYDR5004
Status last verified
Jun 2019
First submitted
28 Sep 2018
Last updated
28 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sukhikh GT, Adamyan LV, Dubrovina SO, Baranov II, Bezhenar VF, Kozachenko AV, Radzinsky VE, Orazov MR, Yarmolinskaya MI, Olofsson JI. Prolonged cyclical and continuous regimens of dydrogesterone are effective for reducing chronic pelvic pain in women with endometriosis: results of the ORCHIDEA study. Fertil Steril. 2021 Dec;116(6):1568-1577. doi: 10.1016/j.fertnstert.2021.07.1194. Epub 2021 Aug 28.

    PubMed 34465452

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Abbott at 21 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in chronic pelvic pain intensity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03690765, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.

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