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Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

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ClinicalTrials.gov Identifier: NCT03789123
Recruitment Status : 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

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
Ovarian Reserve Drug: Estradiol valerate/dienogest Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019


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 Name: 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 Name: Dienogest




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Endometrioma Size [ Time Frame: up to 24 months ]
    The investigators evaluate endometrioma size (centimeter) using ultrasonography.

  2. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789123


Contacts
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Contact: Tolga Karacan, M.D 05303638765 tolgakaracan84@gmail.com

Locations
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Turkey
Tolga Karacan Recruiting
İstanbul, Bagcilar, Turkey, 34100
Contact: Tolga Karacan, M.D    5303638765    tolgakaracan84@gmail.com   
Sub-Investigator: Gulfem Basol, M.D         
Sub-Investigator: Fatma V Ferit, Prof.Dr.M.D         
Sub-Investigator: Eser Ozyurek, M.D         
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
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Study Director: Engin Oral, Prof.Dr. M.D Istanbul University Cerrahpasa Medical Faculty

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Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03789123     History of Changes
Other Study ID Numbers: 2018.11.1.01.082.r1.101
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol Valerate, dienogest drug combination
Estradiol
Polyestradiol phosphate
Endometriosis
Genital Diseases, Female
Dienogest
Nandrolone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Anabolic Agents