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Completed

NCT Number: NCT01631981

PGL2001 Proof of Concept Study in Symptomatic Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PGL2001 + Primolut-Nor 5

Drug

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.

Placebo + Primolut-Nor 5

Drug

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.

Primary outcomes

  1. Non-menstrual pelvic pain.

    Time frame: Daily collection up to 16 weeks

    Use of a Visual Analogue Scale (VAS).

Sponsors and collaborators

Lead sponsor

PregLem SA

Industry

Registry information

Official study title

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

Acronym: AMBER

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 29, 2012
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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