A PHASE II, RANDOMIZED, DOUBLE BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMY109 IN WOMEN WITH ENDOMETRIOSIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507289-14-00

Acronym

AMY106EU

Enrollment

Registered

2024-05-16

Start date

2024-10-21

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment

Interventions

DRUGNAPROXEN

DRUGPlacebo to match desogestrel

DRUGPlacebo to match AMY109

DRUGCODEINE PHOSPHATE

DRUGDESOGESTREL

DRUGTRAMADOL HYDROCHLORIDE

DRUGFeanolla 75 microgram film-coated tablets

DRUGNAPROXEN SODIUM

DRUGPARACETAMOL

DRUGIBUPROFEN

DRUGAMY109

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Changes of total score and stage in the revised American Society of Reproductive Medicine (r-ASRM) score assessed by laparoscopy from pre-treatment to post-treatment (only in the UK) Change in sum of long (i.e., the largest) diameters of endometriotic nodules assessed by MRI from pre-treatment to post-treatment	—

Countries

Czechia, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026