Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02728245
Other study ID # SNUBH_GO_052
Secondary ID
Status Withdrawn
Phase Phase 2
First received March 19, 2016
Last updated October 28, 2017
Start date October 2017
Est. completion date March 2018

Study information

Verified date October 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dienogest
Dienogest 2mg po qd
Placebo drug
Placebo 1 table po qd
Procedure:
Surgery
conservative surgery without intent to oophorectomy

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Si Gyeonggi Do

Sponsors (6)

Lead Sponsor Collaborator
Seoul National University Hospital Ajou University School of Medicine, Asan Medical Center, Ewha Womans University Mokdong Hospital, Korea University Guro Hospital, Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the mean change of serum Anti-Mullerian Hormone (AMH) level 3 month after surgery
Secondary Compare the mean change of serum AMH level 1 month after surgery
Secondary Compare the trend of mean change of serum AMH level 1 and 3 month after surgery
Secondary Compare the mean change of serum AMH level baseline and after preoperative dienogest/placebo therapy for 3 months
Secondary Compare the revised American fertility society (AFS) score At surgery
Secondary compare the surgical time (minute) surgical time (minute) intraoperative
Secondary Brief Pain Inventory (BPI) scores baseline, 1 month after surgery and 3 month after surgery
Secondary number of participants with treatment-related adverse events as assessed by CTCAE v4.0 All adverse events from randomization to postoperative 3 months
Secondary Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months baseline and after preoperative dienogest/placebo therapy for 3 months
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4