NCT00630539 is a Phase 2 clinical trial of Ospemifene 5 mg in Atrophy, sponsored by Shionogi.

Who is sponsoring NCT00630539?

NCT00630539 is sponsored by Shionogi.

What drugs are being tested in NCT00630539?

Interventions in NCT00630539: Placebo, Ospemifene 5 mg, Ospemifene 15 mg, Ospemifene 30 mg.

What condition does NCT00630539 study?

NCT00630539 studies Atrophy, Vaginal Diseases.

Is NCT00630539 still recruiting?

NCT00630539 is currently completed. Last updated 21 May 2013.

Are results published for NCT00630539?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-05-21 · How we verify

NCT00630539

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

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Completed Phase 2 Results posted Last updated 21 May 2013

What this trial tests

Phase 2 trial testing Placebo in Atrophy in 126 participants. Completed in 1 February 2008.

Timeline

1 August 2007

Primary endpoint
1 January 2008

1 February 2008

Quick facts

Lead sponsor	Shionogi
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	126
Start date	1 August 2007
Primary completion	1 January 2008
Estimated completion	1 February 2008

Drugs / interventions tested

Placebo
Ospemifene 5 mg — full drug profile →
Ospemifene 15 mg — full drug profile →
Ospemifene 30 mg — full drug profile →

Conditions studied

Atrophy — all drugs for Atrophy →
Vaginal Diseases — all drugs for Vaginal Diseases →

Sponsor

Shionogi — full company profile →

Who can join

Adults 40 to 80, female only, with Atrophy or Vaginal Diseases. 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.

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear
Time frame: 12 weeks
Mean Change From Baseline in Vaginal pH
Time frame: 12 weeks

Sponsor's own description

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

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:

Other recruiting trials for Atrophy

Currently open trials in the same condition.

NCT05698316 — A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Predicti · active not recruiting
NCT05626855 — Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab · Phase 3 · active not recruiting

Other Shionogi trials

Trials by the same sponsor.

NCT07214571 — A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of · Phase 2 · recruiting
NCT07123155 — Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD) · Phase 2 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07018492 — Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls · Phase 1 · completed
NCT07012005 — Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls · Phase 1 · completed

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 NCT00630539 (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 Shionogi
Last refreshed: 21 May 2013

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/NCT00630539.

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