Trial Outcomes & Findings for Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women (NCT NCT05367973)
NCT ID: NCT05367973
Last Updated: 2024-10-31
Results Overview
To assess the safety and tolerability of DARE-HRT1 Intravaginal rings
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women
Baseline characteristics by cohort
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=10 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 3.41 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 4.74 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 4.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Body Mass Index
|
25.9 kg/m^2
STANDARD_DEVIATION 3.53 • n=5 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 4.62 • n=7 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.26 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo assess the safety and tolerability of DARE-HRT1 Intravaginal rings
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=10 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
11 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28 day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=10 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Maximum Plasma Concentration of Progesterone (Cmax) Per Cycle
|
5.16 ng/mL
Geometric Coefficient of Variation 43.83
|
2.40 ng/mL
Geometric Coefficient of Variation 36.8
|
2.71 ng/mL
Geometric Coefficient of Variation 30.95
|
8.45 ng/mL
Geometric Coefficient of Variation 37.75
|
3.46 ng/mL
Geometric Coefficient of Variation 15.73
|
3.38 ng/mL
Geometric Coefficient of Variation 10.01
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28 day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=10 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Time That Maximum Progesterone Plasma Concentration Was Observed (Tmax)
|
23.23 hours
Interval 7.85 to 24.2
|
24.08 hours
Interval 0.5 to 48.3
|
0.500 hours
Interval 0.05 to 23.03
|
23.25 hours
Interval 23.0 to 24.82
|
23.67 hours
Interval 1.0 to 47.95
|
4.00 hours
Interval 0.48 to 48.17
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=7 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Progesterone Steady-state Concentration (Css) Per Cycle
|
1.06 ng/mL
Geometric Coefficient of Variation 25.57
|
1.08 ng/mL
Geometric Coefficient of Variation 27.49
|
1.21 ng/mL
Geometric Coefficient of Variation 26.72
|
1.83 ng/mL
Geometric Coefficient of Variation 26.10
|
1.68 ng/mL
Geometric Coefficient of Variation 13.39
|
1.78 ng/mL
Geometric Coefficient of Variation 15.41
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28 day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=10 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Time That Maximum Estradiol Plasma Concentration Was Observed (Tmax)
|
24.20 hours
Interval 22.07 to 48.05
|
47.48 hours
Interval 23.28 to 167.08
|
47.26 hours
Interval 23.03 to 48.43
|
47.09 hours
Interval 23.07 to 48.85
|
47.95 hours
Interval 23.23 to 170.87
|
47.26 hours
Interval 23.07 to 48.23
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28 day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=10 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Maximum Plasma Concentration of Estradiol (Cmax) Per Cycle
|
68.29 pg/mL
Geometric Coefficient of Variation 27.29
|
41.67 pg/mL
Geometric Coefficient of Variation 35.91
|
44.56 pg/mL
Geometric Coefficient of Variation 21.00
|
107.76 pg/mL
Geometric Coefficient of Variation 34.17
|
66.89 pg/mL
Geometric Coefficient of Variation 31.66
|
71.06 pg/mL
Geometric Coefficient of Variation 34.48
|
PRIMARY outcome
Timeframe: 12 weeks (3- 28day cycles)To describe the Pharmacokinetic parameters of dose combinations (Estradiol 80 ug/progesterone 4/mg day and Estradiol 160 ug/progesterone 8/mg day)
Outcome measures
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 Participants
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=11 Participants
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 80 ug/Day + Progesterone 4 mg/Day Cycle 3
n=10 Participants
28 day IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day Cycle 1
n=10 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 2
n=9 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
IVR: Estradiol 160 ug/Day + Progesterone 8mg/Day Cycle 3
n=8 Participants
28 day IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|---|---|---|---|
|
Determination of Estradiol Steady-state Concentration (Css) Per Cycle
|
21.87 pg/mL
Geometric Coefficient of Variation 36.92
|
22.55 pg/mL
Geometric Coefficient of Variation 22.83
|
21.79 pg/mL
Geometric Coefficient of Variation 20.15
|
37.28 pg/mL
Geometric Coefficient of Variation 22.17
|
36.43 pg/mL
Geometric Coefficient of Variation 24.00
|
37.52 pg/mL
Geometric Coefficient of Variation 27.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo assess usability and participant tolerability of the DARE-HRT1 Intravaginal Ring comparing total questionnaire score from baseline to end of study with a decrease in score showing improvement.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo conduct a preliminary evaluation of the effect of the DARE-HRT1 intravaginal ring on Vulvarvaginal atrophy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo conduct a preliminary evaluation of the effect of the DARE-HRT1 intravaginal ring on Vulvarvaginal atrophy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo conduct a preliminary evaluation of the effect of the DARE-HRT1 intravaginal ring on Vasomotor Symptoms (VMS)
Outcome measures
Outcome data not reported
Adverse Events
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IVR: Estradiol 80 ug/Day + Progesterone 4mg/Day
n=11 participants at risk
12-week IVR 80/4
IVR Dose 1: Estradiol 80 ug/day + progesterone 4 mg/day
|
IVR Estradiol 160 ug/Day + Progesterone 8 mg/Day
n=10 participants at risk
12-week IVR 160/8
IVR Dose 2: Estradiol 160 ug/day + progesterone 8 mg/day
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
40.0%
4/10 • Number of events 6 • 12 weeks
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 2 • 12 weeks
|
|
Reproductive system and breast disorders
Postmenopausal hemorrhage
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
Nipple pain
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
30.0%
3/10 • Number of events 3 • 12 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
20.0%
2/10 • Number of events 4 • 12 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/11 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/11 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Nervous system disorders
Headache
|
54.5%
6/11 • Number of events 9 • 12 weeks
|
50.0%
5/10 • Number of events 11 • 12 weeks
|
|
Nervous system disorders
Sensory distrubance
|
0.00%
0/11 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Infections and infestations
COVID-19
|
18.2%
2/11 • Number of events 6 • 12 weeks
|
20.0%
2/10 • Number of events 5 • 12 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
18.2%
2/11 • Number of events 2 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Number of events 3 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
30.0%
3/10 • Number of events 5 • 12 weeks
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
Additional Information
Jessica Hatheway, VP Clinical Operations
Dare Bioscience, Inc.
Phone: 858-926-7655
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI are not allowed to publish without prior approval from Sponsor.
- Publication restrictions are in place
Restriction type: OTHER