Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
Primary Purpose
Ovarian Reserve
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Estradiol valerate/dienogest
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Reserve focused on measuring Endometrioma, Estradiol valerate + dienogest, Dienogest, Ovarian reserve
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Sites / Locations
- Tolga KaracanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Study Group (patients with OMA)
Control Group(patients without OMA)
Arm Description
I) Untreated patients (n=142) II) Dienogest (n=142) III) Dienogest/Estradiol valerate+Dienogest (n=142)
I) Untreated patients (n=142) II) Dienogest/Estradiol valerate+Dienogest (n=142)
Outcomes
Primary Outcome Measures
Ovarian reserve
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.
Secondary Outcome Measures
Endometrioma Size
The investigators evaluate endometrioma size (centimeter) using ultrasonography.
Pain Score
Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
Full Information
NCT ID
NCT03789123
First Posted
November 22, 2018
Last Updated
December 27, 2018
Sponsor
Bagcilar Training and Research Hospital
Collaborators
Kocaeli Derince Education and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03789123
Brief Title
Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
Official Title
Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital
Collaborators
Kocaeli Derince Education and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Reserve
Keywords
Endometrioma, Estradiol valerate + dienogest, Dienogest, Ovarian reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
710 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group (patients with OMA)
Arm Type
Experimental
Arm Description
I) Untreated patients (n=142)
II) Dienogest (n=142)
III) Dienogest/Estradiol valerate+Dienogest (n=142)
Arm Title
Control Group(patients without OMA)
Arm Type
Sham Comparator
Arm Description
I) Untreated patients (n=142)
II) Dienogest/Estradiol valerate+Dienogest (n=142)
Intervention Type
Drug
Intervention Name(s)
Estradiol valerate/dienogest
Other Intervention Name(s)
Dienogest
Intervention Description
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
Primary Outcome Measure Information:
Title
Ovarian reserve
Description
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.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Endometrioma Size
Description
The investigators evaluate endometrioma size (centimeter) using ultrasonography.
Time Frame
up to 24 months
Title
Pain Score
Description
Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
Time Frame
up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tolga Karacan, M.D
Phone
05303638765
Email
tolgakaracan84@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Engin Oral, Prof.Dr. M.D
Organizational Affiliation
Istanbul University Cerrahpasa Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Tolga Karacan
City
İstanbul
State/Province
Bagcilar
ZIP/Postal Code
34100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tolga Karacan, M.D
Phone
5303638765
Email
tolgakaracan84@gmail.com
First Name & Middle Initial & Last Name & Degree
Gulfem Basol, M.D
First Name & Middle Initial & Last Name & Degree
Fatma V Ferit, Prof.Dr.M.D
First Name & Middle Initial & Last Name & Degree
Eser Ozyurek, M.D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
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