Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789123
Recruitment Status : Unknown
Verified December 2018 by Bagcilar Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Collaborators:
Kocaeli Derince Education and Research Hospital
Suleymaniye Birth And Women's Health Education And Research Hospital
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE November 22, 2018
First Posted Date  ICMJE December 28, 2018
Last Update Posted Date December 28, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
Ovarian reserve [ Time Frame: up to 24 months ]
The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Endometrioma Size [ Time Frame: up to 24 months ]
    The investigators evaluate endometrioma size (centimeter) using ultrasonography.
  • Pain Score [ Time Frame: up to 24 months ]
    Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
Official Title  ICMJE Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
Brief Summary Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Reserve
Intervention  ICMJE Drug: Estradiol valerate/dienogest
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
Other Name: Dienogest
Study Arms  ICMJE
  • Experimental: Study Group (patients with OMA)

    I) Untreated patients (n=142)

    II) Dienogest (n=142)

    III) Dienogest/Estradiol valerate+Dienogest (n=142)

    Intervention: Drug: Estradiol valerate/dienogest
  • Sham Comparator: Control Group(patients without OMA)

    I) Untreated patients (n=142)

    II) Dienogest/Estradiol valerate+Dienogest (n=142)

    Intervention: Drug: Estradiol valerate/dienogest
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
710
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
  2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion Criteria:

  • suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789123
Other Study ID Numbers  ICMJE 2018.11.1.01.082.r1.101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bagcilar Training and Research Hospital
Study Sponsor  ICMJE Bagcilar Training and Research Hospital
Collaborators  ICMJE
  • Kocaeli Derince Education and Research Hospital
  • Suleymaniye Birth And Women's Health Education And Research Hospital
Investigators  ICMJE
Study Director: Engin Oral, Prof.Dr. M.D Istanbul University Cerrahpasa Medical Faculty
PRS Account Bagcilar Training and Research Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP