Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01778985
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : September 10, 2014
Last Update Posted : October 2, 2014
Sponsor:
Collaborator:
American Urogynecologic Society Foundation Astellas Research Award
Information provided by (Responsible Party):
David Rahn, MD, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Pelvic Organ Prolapse
Menopause
Interventions Drug: Premarin
Other: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Premarin Placebo
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 15 15
Completed 8 12
Not Completed 7 3
Reason Not Completed
Lost to Follow-up             1             0
Physician Decision             2             2
Protocol Violation             4             1
Arm/Group Title Premarin Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
55.1  (5.4) 58.9  (5.1) 57.2  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
15
 100.0%
15
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Non-Hispanic White 7 2 9
Non-Hispanic Black 1 3 4
Hispanic White 7 10 17
Parity  
Median (Inter-Quartile Range)
Unit of measure:  Deliveries
Number Analyzed 15 participants 15 participants 30 participants
3
(2 to 4)
4
(3 to 6)
4
(3 to 6)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 15 participants 30 participants
29.2  (5.4) 31.7  (4.1) 30.5  (4.9)
1.Primary Outcome
Title Vaginal Wall Composition: Epithelium (Intention to Treat)
Hide Description Will assess vaginal wall histology - thicknesses of epithelium
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis ("intention to treat")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: microns
413.9  (63.7) 314.1  (42.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Vaginal Wall Composition: Epithelium (Per-Protocol)
Hide Description Will assess vaginal wall histology - thicknesses of epithelium
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication ("per protocol")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: microns
550.5  (45.1) 314.1  (42.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Vaginal Wall Composition: Muscularis (Intention to Treat)
Hide Description Will assess vaginal wall histology - thicknesses of muscularis
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis ("intention to treat")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: microns
5670.4  (2154.7) 2807.1  (622.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Vaginal Wall Composition: Muscularis (Per-Protocol)
Hide Description Will assess vaginal wall histology - thicknesses of muscularis
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication ("per protocol")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: microns
7570.7  (3193.1) 2807.1  (622.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method t-test, 2 sided
Comments t(18)=1.78, p=0.088
5.Primary Outcome
Title hCOL1A1, Per-Protocol
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication ("per protocol")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Median (Inter-Quartile Range)
Unit of Measure: ratio
2.19
(1.52 to 2.91)
0.37
(0.18 to 0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Total Collagen Content in Vaginal Muscularis, (Per-Protocol)
Hide Description Will assess hydroxy-proline assays as index of amount of collagen
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication ("per protocol")
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: mg collagen per mg muscularis wet weight
302.6  (146.1) 94.86  (29.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments t(18)=1.69, p=.10
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Vaginal Wall Degradative Activity, Muscularis, MMP-9
Hide Description Will assess zymograms for total matrix metalloprotease (MMP) 9 activity
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All specimens with sufficient amount of tissue available for zymography analysis were used.
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 7 8
Mean (Standard Error)
Unit of Measure: Relative Units/mg protein
37.03  (15.06) 132.34  (35.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments t(10)=2.76, p=0.020
Method t-test, 2 sided
Comments [Not Specified]
8.Primary Outcome
Title Vaginal Wall Composition: Lamina Propria (Intention to Treat)
Hide Description Will assess vaginal wall histology - thickness of lamina propria.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: microns
1042.3  (169.8) 895.1  (153.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Primary Outcome
Title Vaginal Wall Composition: Lamina Propria (Per-Protocol)
Hide Description Will assess vaginal wall histology - thickness of lamina propria
Time Frame Time of surgery, i.e. 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: microns
1133.4  (166.2) 895.1  (153.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Primary Outcome
Title hCOL3, (Per-Protocol)
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Median (Inter-Quartile Range)
Unit of Measure: ratio
.92
(.6 to 1.44)
.37
(.18 to .95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Primary Outcome
Title Lysyl Oxidase (LOX) (Per-Protocol)
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: ratio
.74  (.14) .51  (.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Primary Outcome
Title LOXL1 (Per-Protocol)
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: ratio
.64  (.12) .69  (.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Primary Outcome
Title Tropoelastin (Per-Protocol)
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: ratio
.78  (.24) .69  (.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Primary Outcome
Title TGFB1 (Per-Protocol)
Hide Description Data represent ratio of total mRNA relative to postmenopausal external control.
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 8 12
Mean (Standard Error)
Unit of Measure: ratio
.61  (.13) .81  (.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Primary Outcome
Title Vaginal Wall Degradative Activity, Mucosa, MMP-9
Hide Description Will assess zymograms for total matrix metalloprotease (MMP) 9 activity
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All specimens with sufficient amount of tissue available for zymography analysis were used.
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 7 8
Mean (Standard Error)
Unit of Measure: Relative Units/mg protein
8.97  (1.77) 56.73  (23.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title Serum Estrone Levels, Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: pg/mL
18.0  (2.3) 18.5  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments t(28)=0.11, p=0.91
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title Serum Estrone Levels, Surgery
Hide Description [Not Specified]
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 12 13
Mean (Standard Error)
Unit of Measure: pg/mL
22.8  (3.5) 24.9  (6.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments t(23)=0.28, p=0.78
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Serum Estradiol Levels, Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 15 15
Mean (Standard Error)
Unit of Measure: pg/mL
11.1  (3.7) 8.4  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments t(28)=0.67, p=0.51
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Serum Estradiol Levels, Surgery
Hide Description [Not Specified]
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 12 13
Mean (Standard Error)
Unit of Measure: pg/mL
7.8  (1.3) 11.6  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments t(23)=1.23, p=0.24
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Estimated Blood Loss
Hide Description Intraoperative estimated blood loss
Time Frame Time of surgery, i.e. after 6-8 weeks of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
In both study arms, 13 participants did undergo surgery and, therefore, had an estimated blood loss value available for analysis. However, one patient each from both study arms did not have biopsies taken (technical considerations/ intraoperative decision or conversion from total to supracervical hysterectomy without ability to collect biopsy).
Arm/Group Title Premarin Placebo
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: mL
285  (134) 285  (270)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 - 8 weeks of preoperative use of vaginal estrogen (vs placebo) cream
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premarin Placebo
Hide Arm/Group Description

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 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

All-Cause Mortality
Premarin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Premarin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Premarin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      0/15 (0.00%)    
Reproductive system and breast disorders     
Vulvovaginal pain   2/15 (13.33%)  2 0/15 (0.00%) 
Annoyance with cream use   1/15 (6.67%)  1 0/15 (0.00%) 
Indicates events were collected by systematic assessment
4 patients nonadherent to study protocol in the Premarin arm.
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
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
First Submitted: January 23, 2013
First Posted: January 29, 2013
Results First Submitted: May 20, 2014
Results First Posted: September 10, 2014
Last Update Posted: October 2, 2014