Last reviewed · How we verify
NCT00160173
Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Phase 4 trial testing Estrogel in Postmenopausal Symptoms in 221 participants. Completed in 6 September 2005.
6 September 2005
Quick facts
| Lead sponsor | ASCEND Therapeutics |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 221 |
| Start date | 2 December 2004 |
| Primary completion | 6 September 2005 |
| Estimated completion | 6 September 2005 |
| Sites | 109 locations across United States |
Drugs / interventions tested
- Estrogel — full drug profile →
- Placebo
Conditions studied
- Postmenopausal Symptoms — all drugs for Postmenopausal Symptoms →
Sponsor
ASCEND Therapeutics — full company profile →
Who can join
Adults 45 to 65, female only, with Postmenopausal Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00160173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Estrogel
Trials testing the same drug.
- NCT03556800 — Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a T · Phase 1 · unknown
Other recruiting trials for Postmenopausal Symptoms
Currently open trials in the same condition.
- NCT06419972 — Multimodal Program for Climacteric Women · NA · recruiting
- NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
- NCT05351476 — Exercise Training and Fat Metabolism in Postmenopausal Women · NA · recruiting
- NCT04893226 — Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women · NA · recruiting
- NCT06794346 — Sexual Effects of Transdermal or Vaginal Testosterone · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00160173 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ASCEND Therapeutics
- Last refreshed: 13 September 2022
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/NCT00160173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing