Ovarian ReservePhase 2DOROSYNCT02728245
Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
A Phase 2 study testing Dienogest and Surgery in people with Ovarian Reserve and Endometriosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Ovarian Reserve, Endometriosis
- What is being tested?
- Dienogest and Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2017to Mar 2018
- Phase
- Phase 2
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
- In Patients with previous unilateral salpingo-oophorectomy (USO)
- Unilateral ovarian endometrioma with any size is eligible
- 20 ≤ Age ≤ 45 and premenopause
- Plan to undergo conservative surgery for endometriomas
Who cannot join
- Pregnant women or women who were suspected to be pregnant
- Women with current venous thromboembolism or history of such diseases
- Women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases
- Women with current diabetes with vascular lesions or history of such diseases
- Women with current severe liver diseases or history of severe liver diseases with abnormal liver function
- Women with current liver tumor or history of liver tumor
Show all 13Show fewer
- Women with current or history of sex-hormone dependent malignant tumor or women who were suspected to have a sex-hormone dependent malignant tumor
- Women with vaginal bleeding of unknown causes
- Women with a history of allergic reaction to elements of DNG
- Women with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Women whose non-compliance is expected
- Lactation (treatment with DNG is not recommended in lactating women due to possible excretion in breast milk)
- Any medication that could result in an excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
About this study
Official title: Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
- Conditions
- Ovarian Reserve, Endometriosis
- Being tested
- Dienogest, Placebo drug, Surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Dienogest 2mg po qd
Placebo drugDrug
Placebo 1 table po qd
SurgeryProcedure or surgery
conservative surgery without intent to oophorectomy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Placebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. Receives: Drug: Dienogest; Drug: Placebo drug; Procedure: Surgery |
| Case group | Experimental | Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. Receives: Drug: Dienogest; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
Measured: 3 month after surgery
Secondary outcomes (8)
Compare the mean change of serum AMH level
Measured: 1 month after surgery
Compare the trend of mean change of serum AMH level
Measured: 1 and 3 month after surgery
Compare the mean change of serum AMH level
Measured: baseline and after preoperative dienogest/placebo therapy for 3 months
Compare the revised American fertility society (AFS) score
Measured: At surgery
compare the surgical time (minute)
surgical time (minute)
Measured: intraoperative
Brief Pain Inventory (BPI) scores
Measured: baseline, 1 month after surgery and 3 month after surgery
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: All adverse events from randomization to postoperative 3 months
Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
Measured: baseline and after preoperative dienogest/placebo therapy for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startOct 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Placebo cannot be prepared
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Korea University Guro Hospital, Ajou University School of Medicine, Ewha Womans University Mokdong Hospital, Asan Medical Center
- Responsible party
- Principal investigator, Kidong Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728245
- Sponsor's protocol ID
- SNUBH_GO_052
- Acronym
- DOROSY
- Status last verified
- Oct 2017
- First submitted
- 19 Mar 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT02728245
- Acronym / sponsor ID
- DOROSY / SNUBH_GO_052
- Conditions
- Ovarian Reserve, Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Placebo cannot be prepared
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Korea University Guro Hospital, Ajou University School of Medicine, Ewha Womans University Mokdong Hospital, Asan Medical Center
- Study start
- Oct 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Dienogest, Drug: Placebo drug, Procedure: SurgeryPlacebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients. Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. |
| Case group | Experimental | Drug: Dienogest, Procedure: SurgeryDienogest(DNG) 2mg 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients. Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
- In Patients with previous unilateral salpingo-oophorectomy (USO)
- Unilateral ovarian endometrioma with any size is eligible
- 20 ≤ Age ≤ 45 and premenopause
- Plan to undergo conservative surgery for endometriomas
Key exclusion criteria (13 listed)
- Pregnant women or women who were suspected to be pregnant
- Women with current venous thromboembolism or history of such diseases
- Women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases
- Women with current diabetes with vascular lesions or history of such diseases
- Women with current severe liver diseases or history of severe liver diseases with abnormal liver function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DienogestDienogest 2mg po qd | Drug | Case group, Control group |
| Placebo drugPlacebo 1 table po qd | Drug | Control group |
| Surgeryconservative surgery without intent to oophorectomy | Procedure or surgery | Case group, Control group |
Primary outcome
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
Time frame: 3 month after surgery
8 secondary outcomes
Compare the mean change of serum AMH level
Time frame: 1 month after surgery
Compare the trend of mean change of serum AMH level
Time frame: 1 and 3 month after surgery
Compare the mean change of serum AMH level
Time frame: baseline and after preoperative dienogest/placebo therapy for 3 months
Compare the revised American fertility society (AFS) score
Time frame: At surgery
compare the surgical time (minute)
Time frame: intraoperative
Brief Pain Inventory (BPI) scores
Time frame: baseline, 1 month after surgery and 3 month after surgery
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: All adverse events from randomization to postoperative 3 months
Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months
Time frame: baseline and after preoperative dienogest/placebo therapy for 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Ovarian Reserve
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
Recruiting
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
Multiple Sclerosis
RecruitingObservational study
Anti-Müllerian Hormone in Breast Cancer Clinical Practice
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dienogest and Surgery in people with Ovarian Reserve and Endometriosis, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level (time frame: 3 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2017.