Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy (NCT NCT00361569)

NCT ID: NCT00361569

Last Updated: 2015-04-20

Results Overview

Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 622 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2015-04-20

Participant Flow

Participant milestones

Measure	DR-2041a Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Overall Study STARTED	150	161	155	156
Overall Study COMPLETED	138	150	137	135
Overall Study NOT COMPLETED	12	11	18	21

Reasons for withdrawal

Measure	DR-2041a Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Overall Study Protocol Violation	3	2	4	2
Overall Study Withdrawal by Subject	2	1	9	14
Overall Study Adverse Event	3	5	2	2
Overall Study Lost to Follow-up	2	3	3	2
Overall Study Not specified by investigator	2	0	0	1

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Baseline characteristics by cohort

Measure	DR-2041a n=150 Participants Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=161 Participants Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=155 Participants 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=156 Participants 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Total n=622 Participants Total of all reporting groups
Age, Continuous	60.0 years STANDARD_DEVIATION 6.48 • n=5 Participants	59.3 years STANDARD_DEVIATION 6.10 • n=7 Participants	59.8 years STANDARD_DEVIATION 6.60 • n=5 Participants	58.4 years STANDARD_DEVIATION 6.28 • n=4 Participants	59.4 years STANDARD_DEVIATION 6.36 • n=21 Participants
Age, Customized Between 30 and 80 years	150 participants n=5 Participants	161 participants n=7 Participants	155 participants n=5 Participants	156 participants n=4 Participants	622.0 participants n=21 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	161 Participants n=7 Participants	155 Participants n=5 Participants	156 Participants n=4 Participants	622.0 Participants n=21 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	0.0 Participants n=21 Participants
Region of Enrollment United States	150 participants n=5 Participants	161 participants n=7 Participants	155 participants n=5 Participants	156 participants n=4 Participants	622.0 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints

Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.

Outcome measures

Measure	DR-2041a n=135 Participants Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=146 Participants Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=140 Participants 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=135 Participants 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Mean Change in the Symptom Identified by the Patient to be Most Bothersome	-1.71 Scores on a scale Standard Error 0.0087	-1.77 Scores on a scale Standard Error 0.085	-1.11 Scores on a scale Standard Error 0.086	-1.10 Scores on a scale Standard Error 0.087

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints

Change= Week 12 vaginal pH - Baseline vaginal pH

Outcome measures

Measure	DR-2041a n=135 Participants Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=146 Participants Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=140 Participants 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=135 Participants 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Mean Change in Vaginal pH	-1.48 pH Standard Error 0.073	-1.44 pH Standard Error 0.071	-0.31 pH Standard Error 0.072	-0.38 pH Standard Error 0.073

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints

Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)

Outcome measures

Measure	DR-2041a n=135 Participants Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=146 Participants Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=140 Participants 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=135 Participants 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Mean Change in Maturation Index	31.46 Index Standard Error 1.221	33.27 Index Standard Error 1.191	5.16 Index Standard Error 1.205	8.91 Index Standard Error 1.222

SECONDARY outcome

Timeframe: Up to Week 12

Population: All randomized subjects who received at least one dose of study medication

Any adverse event reported from the beginning of the 28-day screening through the subject's last report.

Outcome measures

Measure	DR-2041a n=150 Participants Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=161 Participants Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=155 Participants 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=156 Participants 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)	83 Participants	87 Participants	72 Participants	77 Participants

Adverse Events

DR-2041a

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

DR-2041b

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo-a

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo-b

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	DR-2041a n=150 participants at risk Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=161 participants at risk Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=155 participants at risk 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=156 participants at risk 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Cardiac disorders Cardiac Chest Pain	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.64% 1/156 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Infections and infestations Chronic Sinusitus	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.62% 1/161 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/156 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Vascular disorders Deep Vein Thrombosis	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.64% 1/156 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.65% 1/155 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/156 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.64% 1/156 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.64% 1/156 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Cardiac disorders Ventricular Tachycardia	0.67% 1/150 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/156 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.

Other adverse events

Measure	DR-2041a n=150 participants at risk Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	DR-2041b n=161 participants at risk Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-a n=155 participants at risk 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Placebo-b n=156 participants at risk 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Gastrointestinal disorders Abdominal pain	0.67% 1/150 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	4.3% 7/161 • Number of events 7 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.65% 1/155 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/156 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/150 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.7% 6/161 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.3% 2/156 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Reproductive system and breast disorders Genital Pruritus Female	2.7% 4/150 • Number of events 4 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.1% 5/161 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.64% 1/156 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Nervous system disorders Headache	4.0% 6/150 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.2% 2/161 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/155 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.8% 6/156 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Vascular disorders Hot Flush	3.3% 5/150 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.2% 2/161 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.3% 2/155 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.2% 5/156 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Vascular disorders Hypertension	0.67% 1/150 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.00% 0/161 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	0.65% 1/155 • Number of events 1 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.2% 5/156 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Infections and infestations Upper Respiratory Tract Infection	4.7% 7/150 • Number of events 7 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.7% 6/161 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	4.5% 7/155 • Number of events 7 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.8% 6/156 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Infections and infestations Urinary Tract Infection	2.0% 3/150 • Number of events 3 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.1% 5/161 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.3% 2/155 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.8% 6/156 • Number of events 6 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Infections and infestations Vulvovaginal Mycotic Infection	4.7% 7/150 • Number of events 7 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.9% 3/161 • Number of events 3 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	3.2% 5/155 • Number of events 5 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.	1.3% 2/156 • Number of events 2 • Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks). Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.

Additional Information

Duramed Research Protocol Chair

Duramed Research

Phone: 215-293-7279

Email: medicalaffairs@barrlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.
• Publication restrictions are in place

Restriction type: OTHER