drugset
drugset / Trial / NCT03789123

Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

NCT03789123 ↗

Phase 4 Unknown 710 enrolled Bagcilar Training and Research Hospital Kocaeli Derince Education and Research Hospital · collabSuleymaniye Birth And Women's Health Education And Research Hospital · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-01-01
Primary completion
2019-07-01
Completion
2019-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dienogest Small molecule — —
Subject estradiol valerate Unknown — —

Indications

No indication recorded.