Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Last updated: December 27, 2018
Sponsor: Bagcilar Training and Research Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Ovarian Function

Endometriosis

Treatment

N/A

Clinical Study ID

NCT03789123
2018.11.1.01.082.r1.101
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 intermittentlycontrolled pain with NSAIDs or no pain symptom

  2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion

Exclusion Criteria:

  • suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intakethat may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previousovarian surgery, AMH levels under 2 ng/ml.

Study Design

Total Participants: 710
Study Start date:
January 01, 2019
Estimated Completion Date:
December 01, 2019

Connect with a study center

  • Tolga Karacan

    İstanbul, Bagcilar 34100
    Turkey

    Active - Recruiting

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