NCT00758953 is a Phase 2 clinical trial of Danazol Once Weekly in Endometriosis, sponsored by Lumara Health, Inc..

Who is sponsoring NCT00758953?

NCT00758953 is sponsored by Lumara Health, Inc..

What drugs are being tested in NCT00758953?

Interventions in NCT00758953: Danazol Once Weekly, Danazol Twice Weekly, Placebo Once Weekly, Placebo Twice Weekly.

What condition does NCT00758953 study?

NCT00758953 studies Endometriosis.

Is NCT00758953 still recruiting?

NCT00758953 is currently completed. Last updated 2 March 2012.

Last reviewed 2012-03-02 · How we verify

NCT00758953

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pain Associated With Endometriosis

Completed Phase 2 Last updated 2 March 2012

What this trial tests

Phase 2 trial testing Danazol Once Weekly in Endometriosis in 66 participants. Completed in 1 January 2009.

Timeline

1 February 2007

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Lumara Health, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	1 February 2007
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	49 locations across United States, Canada, Russia

Drugs / interventions tested

Danazol Once Weekly — full drug profile →
Danazol Twice Weekly — full drug profile →
Placebo Once Weekly — full drug profile →
Placebo Twice Weekly — full drug profile →

Conditions studied

Endometriosis — all drugs for Endometriosis →

Sponsor

Lumara Health, Inc. — full company profile →

Who can join

Adults 18 to 50, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pain associated with endometriosis
Time frame: 3 months of treatment

Sponsor's own description

This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A call for more transparency of registered clinical trials on endometriosis.
Guo SW, Hummelshoj L, Olive DL, Bulun SE, et al · · 2009 · cited 32× · PMID 19264712 · DOI 10.1093/humrep/dep045
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004
Pattern-recognition receptors in endometriosis: A narrative review.
Guo B, Chen JH, Zhang JH, Fang Y, et al · · 2023 · cited 21× · PMID 37033937 · DOI 10.3389/fimmu.2023.1161606
Androgen Signaling in Uterine Diseases: New Insights and New Targets.
Lv M, Yu J, Huang Y, Ma J, et al · · 2022 · cited 13× · PMID 36358974 · DOI 10.3390/biom12111624

Verify or expand the search:

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

NCT06559852 — The Impact of Yoga on Endometriosis-Related Pain · NA · recruiting
NCT07393295 — Efficacy and Tolerability of TENS in Endometriosis-related Pain · NA · recruiting
NCT07134023 — Educational Program for the Multidisciplinary Support of Patients With Endometriosis · NA · recruiting
NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
NCT06974773 — Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00758953 (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 Lumara Health, Inc.
Last refreshed: 2 March 2012

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/NCT00758953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing