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NCT03789123
Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
Phase 4 trial testing Estradiol valerate/dienogest in Ovarian Reserve in 710 participants. Status unknown.
1 July 2019
Quick facts
| Lead sponsor | Bagcilar Training and Research Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 710 |
| Start date | 1 January 2019 |
| Primary completion | 1 July 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Estradiol valerate/dienogest
Conditions studied
- Ovarian Reserve — all drugs for Ovarian Reserve →
Sponsor
Bagcilar Training and Research Hospital
Who can join
Adults 18 to 40, female only, with Ovarian Reserve. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004
Verify or expand the search:
- PubMed search for NCT03789123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ovarian Reserve
Currently open trials in the same condition.
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- NCT06626282 — Fertility and Ovarian Reserve in Female Childhood Cancer Survivors · recruiting
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- NCT04487925 — Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders · Phase 4 · recruiting
Other Bagcilar Training and Research Hospital trials
Trials by the same sponsor.
- NCT07164248 — Evaluation of Bone Mineral Density Indications and Outcomes in Female Adolescents: Implications for Early Detection of O · completed
- NCT07186127 — Methotrexate Treatment in Cases of Ectopic Pregnancy With Relative Contraindications · recruiting
- NCT06515028 — Effects of Anesthesia Technique on Endothelial Function · NA · not yet recruiting
- NCT06497634 — Effect of Spinal Needle Type on Optic Nerve Sheath Diameter · NA · not yet recruiting
- NCT06970821 — Association of Vitamin D Status With Metabolic Markers in Adolescents With Polycystic Ovary Syndrome · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03789123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bagcilar Training and Research Hospital
- Last refreshed: 28 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03789123.
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