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Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03789123
Collaborator
Kocaeli Derince Education and Research Hospital (Other), Suleymaniye Birth And Women's Health Education And Research Hospital (Other)
710
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
64.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Estradiol valerate/dienogest
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
710 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group (patients with OMA)

I) Untreated patients (n=142) II) Dienogest (n=142) III) Dienogest/Estradiol valerate+Dienogest (n=142)

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 Names:
  • Dienogest

    		•
    Sham Comparator: Control Group(patients without OMA)

    I) Untreated patients (n=142) II) Dienogest/Estradiol valerate+Dienogest (n=142)

    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 Names:
  • Dienogest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ovarian reserve [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.

    Secondary Outcome Measures

    1. Endometrioma Size [up to 24 months]

      The investigators evaluate endometrioma size (centimeter) using ultrasonography.

    2. Pain Score [up to 24 months]

      Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tolga Karacan İstanbul Bagcilar Turkey 34100

    Sponsors and Collaborators

    • Bagcilar Training and Research Hospital
    • Kocaeli Derince Education and Research Hospital
    • Suleymaniye Birth And Women's Health Education And Research Hospital

    Investigators

    • Study Director: Engin Oral, Prof.Dr. M.D, Istanbul University Cerrahpasa Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bagcilar Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03789123
    Other Study ID Numbers:
    • 2018.11.1.01.082.r1.101
    First Posted:
    Dec 28, 2018
    Last Update Posted:
    Dec 28, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Bagcilar Training and Research Hospital
    Endometrioma
    Estradiol valerate + dienogest
    Dienogest
    Ovarian reserve
    Additional relevant MeSH terms:
    Endometriosis
    Dienogest
    Estradiol 17 beta-cypionate
    Estradiol 3-benzoate
    Estradiol
    Polyestradiol phosphate
    Nandrolone

    Study Results

    No Results Posted as of Dec 28, 2018