Trial Outcomes & Findings for RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia (NCT NCT03323801)

NCT ID: NCT03323801

Last Updated: 2021-10-26

Results Overview

Number of participants with undetectable or detectable sperm in their ejaculates.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: up to 32 weeks
• Results posted on: 2021-10-26

Participant Flow

Participant milestones

Measure	13-cis Retinoic Acid 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia

Baseline characteristics by cohort

Measure	13-cis Retinoic Acid n=10 Participants 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 32 weeks

Population: Men had idiopathic azoospermia, without evidence of obstruction or know genetic causes of azoospermia, although one man had known AZFc deletion

Number of participants with undetectable or detectable sperm in their ejaculates.

Outcome measures

Measure	Accutane-13-cis Retinoic Acid n=9 Participants 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Total Motile Sperm undetectable	8 Participants
Total Motile Sperm detectable motile sperm	1 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: Only man who developed sperm in ejaculate on treatment

Number of total sperm in ejaculate and percentage of these sperm that were motile

Outcome measures

Measure	Accutane-13-cis Retinoic Acid n=32500 Total sperm in the ejaculate 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Total Sperm and Percentage of These Sperm That Were Motile	20 Percent of sperm that were motile

SECONDARY outcome

Timeframe: 32 weeks

Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid

Outcome measures

Measure	Accutane-13-cis Retinoic Acid n=10 Participants 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Serious and Non-Serious Adverse Effects	1 Participants

Adverse Events

Accutane-13-cis Retinoic Acid

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Accutane-13-cis Retinoic Acid n=10 participants at risk 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Gastrointestinal disorders nephrotic syndrome	10.0% 1/10 • Number of events 1 • 32 weeks

Other adverse events

Measure	Accutane-13-cis Retinoic Acid n=10 participants at risk 20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne
Musculoskeletal and connective tissue disorders cramps	10.0% 1/10 • Number of events 1 • 32 weeks

Additional Information

Dr. John Amory

University of Washington School of Medicine

Phone: 2066161727

Email: jamory@uw.edu

Results disclosure agreements

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