PGL2001 Proof of Concept Study in Symptomatic Endometriosis

A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01631981

Acronym

AMBER

Enrollment

162

Registered

2012-06-29

Start date

2012-06-30

Completion date

2014-05-31

Last updated

2014-06-03

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

Conditions

Endometriosis

Brief summary

This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.

Interventions

DRUGPGL2001 + Primolut-Nor 5

PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.

DRUGPlacebo + Primolut-Nor 5

Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Provide written informed consent prior to initiation of any study related procedures. * Be a woman of reproductive age between 18 and 45 years inclusive. * Present with clinical signs suggestive of endometriosis. * Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion criteria

* Be pregnant or currently lactating. * Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis. * Have had any surgical treatment for endometriosis within the last 12 months. * Have documented significant adenomyosis. * Have participated in another clinical trial within the 30 days prior to the screening visit.

Design outcomes

Primary

Measure	Time frame	Description
Non-menstrual pelvic pain.	Daily collection up to 16 weeks	Use of a Visual Analogue Scale (VAS).

Countries

Hungary, Poland, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026