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Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

NCT03789123 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2018-12-28

No results posted yet for this 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.

Conditions

  • Ovarian Reserve

Interventions

DRUG

Estradiol valerate/dienogest

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

Sponsors & Collaborators

  • Kocaeli Derince Education and Research Hospital

    collaborator OTHER

  • Suleymaniye Birth And Women's Health Education And Research Hospital

    collaborator OTHER_GOV

  • Bagcilar Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Engin Oral, Prof.Dr. M.D · Istanbul University Cerrahpasa Medical Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789123 on ClinicalTrials.gov