Trial Outcomes & Findings for RA-2 13-cis Retinoic Acid (Isotretinoin) (NCT NCT02061384)

NCT ID: NCT02061384

Last Updated: 2021-08-02

Results Overview

Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 20-weeks
• Results posted on: 2021-08-02

Participant Flow

Participant milestones

Measure	13-cis Retinoic Acid + Oral Calcitriol 20 mg 13-cis retinoic acid twice daily (BID) with meals for two weeks + oral calcitriol 0.25 mcg BID	13-cis Retinoic Acid 20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RA-2 13-cis Retinoic Acid (Isotretinoin)

Baseline characteristics by cohort

Measure	13-cis Retinoic Acid n=10 Participants 20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne	13-cis Retinoic Acid + Calcitriol 0.25 mcg n=10 Participants oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks Calcitriol: Calcitriol is a form of vitamin D given twice daily (BID)	Total n=20 Participants Total of all reporting groups
Age, Continuous	36.1 years STANDARD_DEVIATION 5.32 • n=5 Participants	34 years STANDARD_DEVIATION 3.4 • n=7 Participants	34.61 years STANDARD_DEVIATION 4.95 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 20-weeks

Population: First 10 men received isotretinoin alone, next 10 men received both isotretinoin and calcitriol

Millions of sperm per ejaculate in men treated with 13-cis retinoic acid

Outcome measures

Measure	13-cis Retinoic Acid n=10 Participants 20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks 13-cis retinoic acid: Accutane is used for the treatment of severe acne	Calcitriol 0.25 mcg n=10 Participants oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks Calcitriol: Calcitriol is a form of vitamin D given twice daily (BID)
Millions of Sperm Per Ejaculate	2.5 Millions of sperm per ejaculate Interval 0.1 to 5.9	3.8 Millions of sperm per ejaculate Interval 2.1 to 13.0

Adverse Events

13-cis Retinoic Acid + Oral Calcitriol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

13-cis Retinoic Acid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	13-cis Retinoic Acid + Oral Calcitriol n=10 participants at risk 20 mg 13-cis retinoic acid twice daily (BID) with meals for two weeks + oral calcitriol 0.25 mcg BID	13-cis Retinoic Acid n=10 participants at risk 20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	10.0% 1/10 • 2 years	10.0% 1/10 • 2 years

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