NCT03789123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
710

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

November 22, 2018

Last Update Submit

December 27, 2018

Conditions

Ovarian Reserve

Keywords

EndometriomaEstradiol valerate + dienogestDienogestOvarian reserve

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 24 months

Secondary Outcomes (2)

  • Endometrioma Size

    up to 24 months

  • Pain Score

    up to 24 months

Study Arms (2)

Study Group (patients with OMA)

EXPERIMENTAL

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

Drug: Estradiol valerate/dienogest

Control Group(patients without OMA)

SHAM COMPARATOR

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

Drug: Estradiol valerate/dienogest

Interventions

Estradiol valerate/dienogestDRUG

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

Also known as: Dienogest
Control Group(patients without OMA)Study Group (patients with OMA)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tolga Karacan

Istanbul, Bagcilar, 34100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

estradiol valerate-dienogestdienogest

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Engin Oral, Prof.Dr. M.D

    Istanbul University Cerrahpasa Medical Faculty

    STUDY DIRECTOR

Central Study Contacts

Tolga Karacan, M.D

CONTACT

05303638765tolgakaracan84@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

December 28, 2018

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

December 28, 2018

Record last verified: 2018-12

Locations

TU(1)