NCT03789123

Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: Bagcilar Training and Research Hospital · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ovarian Reserve

Interventions

Type	Name	Description
DRUG	Estradiol valerate/dienogest	The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2018-12-28
• Last updated: 2018-12-28

Locations

1 site across 1 country: Turkey (Türkiye)