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CompletedNCT01833663OABUpdated Mar 20, 2014

Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

A Phase 4 interventional study of Solifenacin Succinate Tablets and Estrogen in Overactive Bladder, Postmenopausal Disorder and Urination Disorders, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-20.

Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This study is a multi-site, randomized, opened and parallel-controlled clinical study.

The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.

02

Conditions studied

  • Overactive Bladder
  • Postmenopausal Disorder
  • Urination Disorders

Keywords

  • Overactive Bladder
  • Solifenacin Succinate Tablets
  • Estrogen
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Post-menopausal women aged ≤75.
  • Signing of ICF.
  • Willing to and able to correctly complete the urination diary.
  • Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
  • No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.

Exclusion criteria

Exclusion Criteria:

  • Clinically-significant dysuria(at the investigators' viewpoints).
  • Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
  • At the ongoing intubatton or the intermittent self-intubatton.
  • Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
  • Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
  • Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study).
  • Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions
  • Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose.
  • Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints.
  • Participation in other clinical studies within 30d before the random grouping.
  • No completion of urination diary according to relevant instructions.
  • Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Solifenacin Succinate Tablets and Estrogen capsules

    Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks

    Drug: Solifenacin Succinate Tablets · Drug: Estrogen

  • Active comparator
    Solifenacin Succinate Tablets

    Solifenacin Succinate Tablets (5mg/d) for 12 weeks

    Drug: Solifenacin Succinate Tablets

Interventions

  • DrugSolifenacin Succinate Tablets
  • DrugEstrogen
06

What researchers measure

Primary outcomes

  1. Difference between the mean urination times (24h) at the end of treatment and the baseline value

    Time frame: 12 weeks

Secondary outcomes

  1. Difference between the mean urgent micturition times (24h) and the baseline value

    Time frame: on week 12

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01833663
Lead sponsor
Peking Union Medical College Hospital
Collaborators
Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.
Responsible party
Sponsor
First posted
Apr 17, 2013
Start date
Oct 2011
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Mar 20, 2014

Study contacts

Lan Zhu, doctor
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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