Trial Outcomes & Findings for A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis (NCT NCT02195986)

NCT ID: NCT02195986

Last Updated: 2022-03-09

Results Overview

Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

366 participants

Primary outcome timeframe

Study Day 8

Results posted on

2022-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Estradiol Vaginal Cream Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Overall Study STARTED	146	147	73
Overall Study COMPLETED	143	142	71
Overall Study NOT COMPLETED	3	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Estradiol Vaginal Cream Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Overall Study Adverse Event	3	0	0
Overall Study Withdrawal by Subject	0	3	0
Overall Study Family Emergency	0	0	1
Overall Study Protocol Violation	0	1	1
Overall Study Non-compliance	0	1	0

Baseline Characteristics

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Estradiol Vaginal Cream n=146 Participants Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=147 Participants Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream n=73 Participants Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)	Total n=366 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	128 Participants n=5 Participants	124 Participants n=7 Participants	61 Participants n=5 Participants	313 Participants n=4 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	23 Participants n=7 Participants	12 Participants n=5 Participants	53 Participants n=4 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 5.25 • n=5 Participants	59.6 years STANDARD_DEVIATION 5.88 • n=7 Participants	59.4 years STANDARD_DEVIATION 5.82 • n=5 Participants	59.4 years STANDARD_DEVIATION 5.61 • n=4 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	147 Participants n=7 Participants	73 Participants n=5 Participants	366 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
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	23 Participants n=7 Participants	13 Participants n=5 Participants	66 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=5 Participants	124 Participants n=7 Participants	60 Participants n=5 Participants	300 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	125 Participants n=7 Participants	61 Participants n=5 Participants	316 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	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	146 participants n=5 Participants	147 participants n=7 Participants	73 participants n=5 Participants	366 participants n=4 Participants
Height	162.1 cm STANDARD_DEVIATION 6.43 • n=5 Participants	161.5 cm STANDARD_DEVIATION 6.18 • n=7 Participants	162.6 cm STANDARD_DEVIATION 6.55 • n=5 Participants	161.9 cm STANDARD_DEVIATION 6.35 • n=4 Participants
Weight	69.77 kg STANDARD_DEVIATION 12.74 • n=5 Participants	69.39 kg STANDARD_DEVIATION 12.67 • n=7 Participants	67.61 kg STANDARD_DEVIATION 11.37 • n=5 Participants	69.19 kg STANDARD_DEVIATION 12.44 • n=4 Participants
BMI	26.6 kg/m^2 STANDARD_DEVIATION 4.41 • n=5 Participants	26.6 kg/m^2 STANDARD_DEVIATION 4.56 • n=7 Participants	25.6 kg/m^2 STANDARD_DEVIATION 4.11 • n=5 Participants	26.4 kg/m^2 STANDARD_DEVIATION 4.42 • n=4 Participants

PRIMARY outcome

Timeframe: Study Day 8

Population: The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation

Outcome measures

Outcome measures
Measure	Estradiol Vaginal Cream n=111 Participants Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=117 Participants Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	42 Participants	45 Participants	—

PRIMARY outcome

Timeframe: Study Day 8

Population: The Intent-to-treat (ITT) population was used for the comparison of active treatments versus placebo analysis which consisted of all randomized subjects that used at least one dose of Test, Reference or Placebo and returned for at least one post-baseline visit.

Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5.

Outcome measures

Outcome measures
Measure	Estradiol Vaginal Cream n=125 Participants Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=138 Participants Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream n=65 Participants Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	49 Participants	51 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 8

Population: The Per Protocol population was used for the secondary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed secondary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation

Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.

Outcome measures

Outcome measures
Measure	Estradiol Vaginal Cream n=97 Participants Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=91 Participants Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	72 Participants	63 Participants	—

SECONDARY outcome

Timeframe: Day 8

Population: The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of Estradiol Vaginal Cream, Estrace®, or Placebo and returned for at least one post-baseline visit

Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.

Outcome measures

Outcome measures
Measure	Estradiol Vaginal Cream n=111 Participants Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=107 Participants Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream n=55 Participants Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	82 Participants	77 Participants	33 Participants

Adverse Events

Estradiol Vaginal Cream

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Estrace® 0.01% Cream

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo Vaginal Cream

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Estradiol Vaginal Cream n=146 participants at risk Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=144 participants at risk Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream n=72 participants at risk Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Cardiac disorders Sick Sinus Syndrome	0.68% 1/146 • Number of events 1 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/144 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Cardiac disorders Cardiac Arrest	0.68% 1/146 • Number of events 1 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/144 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Cardiac disorders Pericardial Haemorrhage	0.68% 1/146 • Number of events 1 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/144 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Cardiac disorders Cardiac Tamponade	0.68% 1/146 • Number of events 1 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/144 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.

Other adverse events

Other adverse events
Measure	Estradiol Vaginal Cream n=146 participants at risk Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. Estradiol Vaginal Cream, 0.01%: Estradiol Vaginal Cream, 0.01% (1 x 2 g for 7 days)	Estrace® 0.01% Cream n=144 participants at risk Estrace® 0.01% vaginal cream, administered once daily for 7 days. Estrace® 0.01% cream: Estrace® 0.01% vaginal cream (1 x 2 g for 7 days)	Placebo Vaginal Cream n=72 participants at risk Placebo Vaginal Cream, administered once daily for 7 days. Placebo Vaginal Cream: Placebo Vaginal Cream (1 x 2 g for 7 days)
Gastrointestinal disorders Abdominal Pain	8.2% 12/146 • Number of events 13 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	11.8% 17/144 • Number of events 22 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Reproductive system and breast disorders Vulvovaginal Pruritus	6.2% 9/146 • Number of events 10 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	1.4% 2/144 • Number of events 2 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	2.8% 2/72 • Number of events 2 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Nervous system disorders Headache	6.2% 9/146 • Number of events 11 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	2.8% 4/144 • Number of events 4 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	5.6% 4/72 • Number of events 4 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Reproductive system and breast disorders Breast Tenderness	1.4% 2/146 • Number of events 2 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	5.6% 8/144 • Number of events 8 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.00% 0/72 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/146 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	0.69% 1/144 • Number of events 1 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.	5.6% 4/72 • Number of events 4 • Adverse event data was collected from signing of the ICF until 30 days post study exit on Study Day 8. Adverse events were collected via subject self-reporting in a diary and queries at clinic visits. Only subjects that were confirmed to have received at least 1 dose of study medication were included in the Safety Population (i.e., At risk) for adverse event reporting. The Safety Population consisted of 146 subjects for the Estradiol Vaginal Cream arm, 144 subjects for the Estrace® arm, and 72 subjects for the Placebo arm.

Additional Information

Abhijit Barve, Head of Global Clinical Research

Mylan Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place