Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor (PET)

This study has been completed.
Sponsor:
Collaborator:
American Urogynecologic Society Foundation Astellas Research Award
Information provided by (Responsible Party):
David Rahn, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01778985
First received: January 23, 2013
Last updated: September 18, 2014
Last verified: September 2014
Results First Received: May 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Pelvic Organ Prolapse
Menopause
Interventions: Drug: Premarin
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Premarin

Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Premarin

Placebo

Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Placebo


Participant Flow:   Overall Study
    Premarin     Placebo  
STARTED     15     15  
COMPLETED     8     12  
NOT COMPLETED     7     3  
Lost to Follow-up                 1                 0  
Physician Decision                 2                 2  
Protocol Violation                 4                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Premarin

Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Premarin

Placebo

Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.

Placebo

Total Total of all reporting groups

Baseline Measures
    Premarin     Placebo     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 5.4     58.9  ± 5.1     57.2  ± 5.5  
Gender  
[units: participants]
     
Female     15     15     30  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Non-Hispanic White     7     2     9  
Non-Hispanic Black     1     3     4  
Hispanic White     7     10     17  
Study-Specific Measure  
[units: deliveries]
Median ( Inter-Quartile Range )
  3  
  ( 2 to 4 )  
  4  
  ( 3 to 6 )  
  4  
  ( 3 to 6 )  
Study-Specific Measure  
[units: kg/m^2]
Mean ± Standard Deviation
  29.2  ± 5.4     31.7  ± 4.1     30.5  ± 4.9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Vaginal Wall Composition: Epithelium (Intention to Treat)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

2.  Primary:   Vaginal Wall Composition: Epithelium (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

3.  Primary:   Vaginal Wall Composition: Muscularis (Intention to Treat)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

4.  Primary:   Vaginal Wall Composition: Muscularis (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

5.  Primary:   hCOL1A1, Per-Protocol   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

6.  Primary:   Total Collagen Content in Vaginal Muscularis, (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

7.  Primary:   Vaginal Wall Degradative Activity, Muscularis, MMP-9   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

8.  Primary:   Vaginal Wall Composition: Lamina Propria (Intention to Treat)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

9.  Primary:   Vaginal Wall Composition: Lamina Propria (Per-Protocol)   [ Time Frame: Time of surgery, i.e. 6-8 weeks of intervention ]

10.  Primary:   hCOL3, (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

11.  Primary:   Lysyl Oxidase (LOX) (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

12.  Primary:   LOXL1 (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

13.  Primary:   Tropoelastin (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

14.  Primary:   TGFB1 (Per-Protocol)   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

15.  Primary:   Vaginal Wall Degradative Activity, Mucosa, MMP-9   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]

16.  Secondary:   Serum Estrone Levels, Baseline   [ Time Frame: Baseline ]

17.  Secondary:   Serum Estrone Levels, Surgery   [ Time Frame: Time of surgery ]

18.  Secondary:   Serum Estradiol Levels, Baseline   [ Time Frame: Baseline ]

19.  Secondary:   Serum Estradiol Levels, Surgery   [ Time Frame: Time of surgery ]

20.  Secondary:   Estimated Blood Loss   [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
4 patients nonadherent to study protocol in the Premarin arm.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David D. Rahn, M.D.
Organization: University of Texas Southwestern Medical Center
phone: 214-648-6430
e-mail: david.rahn@utsouthwestern.edu


No publications provided


Responsible Party: David Rahn, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01778985     History of Changes
Other Study ID Numbers: STU-042011-101
Study First Received: January 23, 2013
Results First Received: May 20, 2014
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board