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NCT03421639
Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis
Phase 4 trial testing GnRH analog (11.25mg Leuprolide acetate) in Uterine Adenomyosis in 300 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Centre for Endocrinology and Reproductive Medicine, Italy |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 December 2017 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 3 locations across Albania, Bulgaria, Italy |
Drugs / interventions tested
- GnRH analog (11.25mg Leuprolide acetate) — full drug profile →
- Aromatase inhibitor and GnRH analog — full drug profile →
- Aromatase and GnRH analog (11.25mg Leuprolide acetate) — full drug profile →
Conditions studied
- Uterine Adenomyosis — all drugs for Uterine Adenomyosis →
- Recurrent Implantation Failure — all drugs for Recurrent Implantation Failure →
- Menstrual Pain — all drugs for Menstrual Pain →
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy — full company profile →
Who can join
Adults 30 to 45, female only, with Uterine Adenomyosis or Recurrent Implantation Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.
Islam MS, Afrin S, Jones SI, Segars J. · · 2020 · cited 97× · PMID 32365199 · DOI 10.1210/endrev/bnaa012 -
Current Medical Therapy for Adenomyosis: From Bench to Bedside.
Etrusco A, Barra F, Chiantera V, Ferrero S, et al · · 2023 · cited 53× · PMID 37837497 · DOI 10.1007/s40265-023-01957-7 -
Progesterone Signaling and Uterine Fibroid Pathogenesis; Molecular Mechanisms and Potential Therapeutics.
Ali M, Ciebiera M, Vafaei S, Alkhrait S, et al · · 2023 · cited 30× · PMID 37190026 · DOI 10.3390/cells12081117
Verify or expand the search:
- PubMed search for NCT03421639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Centre for Endocrinology and Reproductive Medicine, Italy trials
Trials by the same sponsor.
- NCT06641440 — Treatment With Prednisone of Women With RPL or RIF Positive to Antithyroid Antibodies and Embryotoxicity Test · Phase 4 · 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 NCT03421639 (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 Centre for Endocrinology and Reproductive Medicine, Italy
- Last refreshed: 6 March 2024
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/NCT03421639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing