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Prednisone for Vasectomy Reversal Outcomes

Phase 4

Waitlist Available

Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-65 years of age

Men undergoing a first-time vasectomy reversal at the Male Fertility and Peyronie's Clinic

Must not have

Prior vasectomy reversal

Current corticosteroid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial looks at the effects of prednisone on sperm parameters and pregnancy rates after a vasectomy reversal. It also assesses any adverse effects of using prednisone.

Who is the study for?

This trial is for men aged 18-65 who want to restore fertility after a vasectomy, have previously fathered a child, and are undergoing their first vasectomy reversal. Their partner must be under 36 with no known fertility issues and not on birth control recently. Men can't join if they've had chemotherapy, testosterone use within the last year, kidney problems, diabetes, high blood pressure or only one testicle.

What is being tested?

The study is looking at how prednisone affects sperm count and quality after a man has his vasectomy reversed. It also aims to see if prednisone changes the chances of getting pregnant post-reversal. The effects will be studied across different ways of using prednisone.

What are the potential side effects?

Possible side effects from taking prednisone may include mood swings, increased appetite leading to weight gain, trouble sleeping (insomnia), slower wound healing or infection due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am a man planning my first vasectomy reversal at the Male Fertility and Peyronie's Clinic.

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My partner and I are trying to get pregnant now.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a vasectomy reversal.

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I am currently taking corticosteroids.

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I have had a fungal infection that spread throughout my body.

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I have had chemotherapy before.

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I have diabetes.

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I have been diagnosed with kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess adverse events with prednisone utilization

Secondary study objectives

Impact of Prednisone on semen concentration post vasectomy reversal

Impact of prednisone on pregnancy rates post vasectomy reversal.

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Prednisone Monthly - ScheduledExperimental Treatment1 Intervention

Group 2 will receive 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be given at the beginning of months 0, 2, and 4 and will be self-administered.

Group II: Prednisone Monthly - As NeededExperimental Treatment1 Intervention

Group 3 will receive a maximum of 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be administered based on sequential semen analyses. If a semen analysis demonstrates a drop in concentration from a prior analysis or if it shows a 0 concentration, the course will be administered.

Group III: Prednisone Every Other WeekExperimental Treatment1 Intervention

Group 4 will receive alternating 1 week dosages of prednisone (1 week on, 1 week off - 5 mg daily only) for a total of 24 weeks

Group IV: ControlActive Control1 Intervention

Group 1 will represent controls and will not receive prednisone in the 3-year post-op period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500