Sperm suppression and contraceptive provided by NET-EN & TU

• Research type

  Research Study

• Full title

  Sperm suppression and contraceptive protection provided Norethisterone Enantate (NET-EN) combined with Testosterone Undecanoate (TU) in healthy men

• Sponsor organisation

  CONRAD Offices

• Eudract number

  2007-005315-26

• Research summary

  This study is important as a long standing goal of the WHO/RHR and CONRAD is to develop a safe, effective and reversible and acceptable form of male hormonal contraception. The main answers we hope to get are: 1. How much will the rate of sperm production decrease when men are given a combination of NET-EN and TU every 8 weeks (maximum 4 injection visits)? 2. What will be the level of contraceptive protection provided by the continued administration of NET- EN and TU every 8 weeks for up to 56 weeks? The potential benefit is being able to use a safe, effective, reversible and acceptable hormonal contraceptive for men; with benefits for women unable to use contraceptives and gives men a more active role in preventing pregnancies. The possible risk from the medications are slight alterations in HDL or LDL (blood components affecting cardiovascular health), a transient elevation in PSA (prostate specific antigen ?? a protein associated with the health of the prostate), change in libido, weight gain, acne, increased red blood cell, testicular shrinkage and enlargement of the breasts. Previous studies of same/similar compounds show the rate of these potential, non serious side effects are low (<1% - 5%). Participation is in 4 phases: screening (up to 8wks) ?? three visits to ensure subject suitability. Suppression (up to 26wks) during which hormone contraceptive treatment is started, along with condoms - phase ends when sperm concentrations reach an acceptable low. Efficacy phase (up to 56 wks) subject will reply wholly on the regimen. Recovery will last until researchers are satisfied sperm concentrations are back to normal and the subject is in good health. Funding will be provided by CONRAD, Eastern Virgina Medical School and the subjects will be recruited at the Manchester Royal Infirmary.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/121

• Date of REC Opinion

  24 Oct 2008

• REC opinion

  Further Information Favourable Opinion