Trial Outcomes & Findings for A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis (NCT NCT00816556)

NCT ID: NCT00816556

Last Updated: 2017-11-13

Results Overview

The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 63 participants
• Primary outcome timeframe: baseline, 12 weeks
• Results posted on: 2017-11-13

Participant Flow

Participant milestones

Measure	Estriol Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Overall Study STARTED	20	21	22
Overall Study COMPLETED	18	19	19
Overall Study NOT COMPLETED	2	2	3

Reasons for withdrawal

Measure	Estriol Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Overall Study Adverse Event	1	1	1
Overall Study Withdrawal by Subject	1	1	1
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis

Baseline characteristics by cohort

Measure	Estriol n=18 Participants Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol n=19 Participants Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo n=19 Participants Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	19 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks

The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.

Outcome measures

Measure	Estriol n=18 Participants Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol n=19 Participants Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo n=19 Participants Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Dryness Severity	3.2 units on a scale Standard Deviation 2.3	2.0 units on a scale Standard Deviation 3.3	2.7 units on a scale Standard Deviation 2.7
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Dryness Bothersomeness	2.3 units on a scale Standard Deviation 2.8	2.1 units on a scale Standard Deviation 2.7	3.6 units on a scale Standard Deviation 3.1
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Itching Severity	1.4 units on a scale Standard Deviation 1.6	2.6 units on a scale Standard Deviation 2.9	1.9 units on a scale Standard Deviation 2.8
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Itching Bothersomeness	1.3 units on a scale Standard Deviation 1.6	2.6 units on a scale Standard Deviation 3.0	1.7 units on a scale Standard Deviation 2.5
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Burning Severity	2.1 units on a scale Standard Deviation 2.6	1.5 units on a scale Standard Deviation 2.5	1.0 units on a scale Standard Deviation 2.9
Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 Burning Bothersomeness	1.9 units on a scale Standard Deviation 2.7	1.5 units on a scale Standard Deviation 2.6	1.1 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: baseline, 2 weeks, 12 weeks

Outcome measures

Measure	Estriol n=18 Participants Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol n=19 Participants Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo n=19 Participants Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks Baseline vs. Week 2	-0.9 pg/ml Standard Deviation 4.6	-1.6 pg/ml Standard Deviation 3.8	0.5 pg/ml Standard Deviation 4.5
Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks Baseline vs. Week 12	1.0 pg/ml Standard Deviation 4.4	1.2 pg/ml Standard Deviation 5.0	1.1 pg/ml Standard Deviation 3.5
Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks Week 2 vs. Week 12	2.2 pg/ml Standard Deviation 5.6	1.5 pg/ml Standard Deviation 3.4	0.6 pg/ml Standard Deviation 4.8

SECONDARY outcome

Timeframe: baseline, 2 weeks, 12 weeks

Outcome measures

Measure	Estriol n=18 Participants Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol n=19 Participants Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo n=19 Participants Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks Baseline vs. Week 2	0.0 pg/ml Standard Deviation 1.1	-1.7 pg/ml Standard Deviation 3.3	0.5 pg/ml Standard Deviation 1.2
Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks Baseline vs. Week 12	-0.4 pg/ml Standard Deviation 3.0	0.6 pg/ml Standard Deviation 1.7	0.2 pg/ml Standard Deviation 1.6
Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks Week 2 vs. Week 12	-0.3 pg/ml Standard Deviation 2.8	1.9 pg/ml Standard Deviation 3.6	-0.3 pg/ml Standard Deviation 1.1

Adverse Events

Estriol

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Estriol n=18 participants at risk Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Estradiol n=19 participants at risk Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks	Placebo n=19 participants at risk Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
Skin and subcutaneous tissue disorders Red Bumpy Rash	5.6% 1/18 • Number of events 1 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	0.00% 0/19 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	0.00% 0/19 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.
Reproductive system and breast disorders Vaginal Spotting	5.6% 1/18 • Number of events 1 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	0.00% 0/19 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	5.3% 1/19 • Number of events 1 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.
Reproductive system and breast disorders Breast tenderness	5.6% 1/18 • Number of events 1 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	0.00% 0/19 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.	0.00% 0/19 • The study coordinator contacted the participants every 2 weeks and asked the questions on the Adverse Events Stopping Rules. The participant was contacted again at 4 weeks after completion of the study to determine if further side effects had occurred. Subjects also completed the Symptoms Inventory Questionnaire at baseline, 2, 4, 8, and 12 weeks. If subjects experienced a serious adverse event they were to be withdrawn from the study. These events included elevated blood pressure, a breakdown of vulvar or vaginal skin, or possible allergy to the medication.

Additional Information

Maire Brid MacBride MB BCh

Mayo Clinic

Phone: 507-538-2271

Email: MacBride.Maire@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place