Trial Outcomes & Findings for Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters (NCT NCT03203681)

NCT ID: NCT03203681

Last Updated: 2021-10-19

Results Overview

Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, 27 Weeks
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	Natesto Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Overall Study STARTED	60
Overall Study 3 Month	44
Overall Study 6 Months	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters

Baseline characteristics by cohort

Measure	Natesto n=60 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race/Ethnicity, Customized Demographics · Caucasian	12 Participants n=5 Participants
Race/Ethnicity, Customized Demographics · Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Demographics · Hispanic	34 Participants n=5 Participants
Race/Ethnicity, Customized Demographics · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Demographics · Other	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 27 Weeks

Testosterone levels measured in ng/dL analyzed from peripheral venous puncture blood draw

Outcome measures

Measure	Natesto n=33 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Change in Testosterone Levels From Baseline to 27 Weeks	652 ng/dL Standard Deviation 305

PRIMARY outcome

Timeframe: Baseline, 27 Weeks

Population: Estradiol levels were not collected for all participants that completed the study

Estradiol levels measured in pg/mL analyzed from peripheral venous puncture blood draw

Outcome measures

Measure	Natesto n=29 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Change in Estradiol Levels From Baseline to 27 Weeks	21.6 pg/mL Standard Deviation 14

PRIMARY outcome

Timeframe: Baseline, 27 Weeks

Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) levels, both measured in mIU/mL analyzed from peripheral venous puncture blood draw

Outcome measures

Measure	Natesto n=33 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Change in Gonadotropin Levels From Baseline to 27 Weeks Follicle Stimulating Hormone	3.0 mIU/mL Standard Deviation 2.9
Change in Gonadotropin Levels From Baseline to 27 Weeks Luteinizing Hormone	2.6 mIU/mL Standard Deviation 3.1

PRIMARY outcome

Timeframe: 27 Weeks

The number of participants with an increase of at least 1 point from their SF-36 QOL scores from baseline will be reported. Short Form-36 (SF-36) Quality of Life (QOL) questionnaire has a proprietary scoring system that ranges from 1-5 and each domain is individually assessed

Outcome measures

Measure	Natesto n=33 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Number of Participants With an Increase in SF-36 QOL Scores From Baseline	32 Participants

PRIMARY outcome

Timeframe: Baseline, 27 Weeks

Sperm count measured in million sperm/mL analyzed from semen sample

Outcome measures

Measure	Natesto n=33 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Change in Sperm Counts From Baseline to 27 Weeks	33.9 million sperm/mL Standard Deviation 24.3

PRIMARY outcome

Timeframe: 27 Weeks

Incidence of adverse events as assessed per treating physician

Outcome measures

Measure	Natesto n=60 Participants Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Incidence of Adverse Events epistaxis	1 Participants
Incidence of Adverse Events Azoospermia	1 Participants
Incidence of Adverse Events Severe Oligospermia	3 Participants
Incidence of Adverse Events Nasal irritation	5 Participants
Incidence of Adverse Events sinusitis	1 Participants

Adverse Events

Natesto

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Natesto n=60 participants at risk Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Reproductive system and breast disorders Azoospermia	1.7% 1/60 • Number of events 1 • 28 weeks
Reproductive system and breast disorders Severe Oligospermia	5.0% 3/60 • Number of events 3 • 28 weeks

Other adverse events

Measure	Natesto n=60 participants at risk Participants in this group will receive Natesto for a 24 consecutive weeks treatment course. Natesto: 4.5% nasal testosterone. 11.0 mg testosterone administered per dose (2 pump actuations, 1 pump per nostril) applied intranasally three times a day.
Injury, poisoning and procedural complications Nasal Irritation	8.3% 5/60 • Number of events 5 • 28 weeks
General disorders Sinusitis	1.7% 1/60 • Number of events 1 • 28 weeks
General disorders Epistaxis	1.7% 1/60 • Number of events 1 • 28 weeks

Additional Information

Dr. Ranjith Ramasamy

University of Miami

Phone: 3052433670

Email: ramasamy@miami.edu

Results disclosure agreements

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