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Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

NCT ID: NCT03789123

Last Updated: 2018-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

710 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Ovarian Reserve

Keywords

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Endometrioma Estradiol valerate + dienogest Dienogest Ovarian reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study Group (patients with OMA)

I) Untreated patients (n=142)

II) Dienogest (n=142)

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

Group Type EXPERIMENTAL

Estradiol valerate/dienogest

Intervention Type DRUG

The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Control Group(patients without OMA)

I) Untreated patients (n=142)

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

Group Type SHAM_COMPARATOR

Estradiol valerate/dienogest

Intervention Type DRUG

The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Interventions

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Estradiol valerate/dienogest

The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Intervention Type DRUG

Other Intervention Names

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Dienogest

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role collaborator

Suleymaniye Birth And Women's Health Education And Research Hospital

OTHER_GOV

Sponsor Role collaborator

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Engin Oral, Prof.Dr. M.D

Role: STUDY_DIRECTOR

Istanbul University Cerrahpasa Medical Faculty

Locations

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Tolga Karacan

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tolga Karacan, M.D

Role: CONTACT

Phone: 05303638765

Email: [email protected]

Facility Contacts

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Tolga Karacan, M.D

Role: primary

Other Identifiers

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2018.11.1.01.082.r1.101

Identifier Type: -

Identifier Source: org_study_id