PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01631981
First received: June 19, 2012
Last updated: May 17, 2013
Last verified: May 2013

June 19, 2012
May 17, 2013
June 2012
October 2013   (final data collection date for primary outcome measure)
Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ] [ Designated as safety issue: No ]
Use of a Visual Analogue Scale (VAS).
Same as current
Complete list of historical versions of study NCT01631981 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endometriosis
  • Drug: PGL2001 + 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.

  • Drug: Placebo + 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.

  • Experimental: PGL2001
    PGL2001 + NETA followed by NETA-only follow-up period
    Intervention: Drug: PGL2001 + Primolut-Nor 5
  • Placebo Comparator: Placebo
    Placebo + NETA followed by NETA-only follow-up period
    Intervention: Drug: Placebo + Primolut-Nor 5
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
May 2014
October 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Poland,   Romania
 
NCT01631981
PGL11-007
No
PregLem SA
PregLem SA
Not Provided
Not Provided
PregLem SA
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP