I have been asked if i would like to participate in a male contraceptive study which envloves testosterone injections. I have been given a brief outline of the study, i thought i would post the details here as this may be of interest to some people.
Let me know your views. Also i dont know if this would have detrimental effects on my gym training (i do not currently use juice, only been training natty.) The reason i think this is because of the frequency of the injections against my natural test levels. (i am aware this will cause full shut down)
----------------------------------------
University of Edinburgh / NHS Lothian
PARTICIPANT INFORMATION SHEET
A25165 "Sperm suppression and contraceptive protection provided by
Norethisterone enanthate (Net-En) combined with Testosterone
Undecanoate (TU) in healthy men."
This is a brief version of the Participant Information Leaflet for the study. We
will give you the full version when you attend to discuss the study in detail.
Summary
The overall purpose of this research is to develop a male contraceptive that is safe,
effective and reversible. This particular study investigates whether a combination of
hormones will prevent pregnancy by decreasing your sperm count in a way that is
fully reversed when treatment stops. We will also watch for any side effects (see
section on page 7), and want to know if you like this treatment as a potential future
contraceptive method. The study is organised by the World Health Organisation.
This research requires you to have a series of paired hormone injections, (one into
each buttock), every 8 weeks, this will be between 16-20 injections over a period of
18 month – depending on the time taken for your sperm to suppress. These
injections aim to switch off sperm production. During the study you have to provide a
brief medical history, undergo physical examinations, provide blood, urine and
semen samples and fill out questionnaires. The study is expected to take up to 27
months.
Participant Selection
You have been asked to participate in this study because you are a healthy man,
(aged 18 to 45) who is in a stable relationship with only one woman (aged 18 to 38)
for at least the past year and you both do not wish her to become pregnant within
the next 2 years.
Although the exact risk is unknown, from previous experience and research,
the potential risk of pregnancy during this study is likely to be similar to using
the female oral contraceptive pill. You will only be included in this study if you
accept this possibility of pregnancy
Information on the drugs
The hormones used in this research are, a progestin called norethisterone
enanthate (abbreviated Net-En) and an androgen called testosterone undecanoate
(abbreviated TU). Both hormones have been tested separately and in combination
for sperm suppression in small numbers of healthy men. Bayer Schering Pharma
AG, in Berlin, Germany, manufactures both hormones.
Procedures and Protocol
• Injections will be given to you every 8 weeks,
This research study consists of four phases:
Phase 1 (Screening) (takes 1 - 2 months to check if you are suitable to enter the
study) you will come to the hospital two or three times.
Phase 2 (Suppression) (lasting up to 6 months from start of treatment and checks
if your sperm output can be suppressed to low enough levels for reliable
contraception)
During Phase 2, you and your partner should continue to use an effective method of
contraception. If your partner is using a hormonal contraceptive before the study,
she will have to stop using it soon after you enter Phase 2 and switch to a non-
hormonal barrier method of contraception (condoms, diaphragm) until your sperm
counts are low enough to enter Phase 3 (Contraceptive Efficacy).
Phase 3 (Efficacy) (lasting about 12 months and checks if the hormone
suppression of sperm output prevents pregnancies)
You and your partner will stop using all other methods of contraception.
You will visit the Unit every 8 weeks for study injections, to provide semen and blood
samples, have physical examinations, complete questionnaires and keep a
menstrual diary.
Phase 4 (Recovery) (this may last for up to 8 months, or rarely longer for a few
men and checks to see your sperm output has returned to normal)
In Phase 4, you and your partner are advised to use another reliable
contraceptive method if you wish to avoid a pregnancy.
Possible side effects of TU
The most frequent undesirable effects of treatment with TU, occurring in between
1% and 10% of men in clinical trials, were acne and pain, itching, redness, swelling,
or bruising at the injection site. Other common side effects included weight gain, hot
flushes, a condition in which there is an increase in blood cells in the body, and
changes in the prostate as described below.
Compensation
For each visit, you will be compensated for your travel to the hospital and other
reasonable expenses. However you and your partner will be compensated for your
time, a total of £500, spread across the duration of the study.
Let me know your views. Also i dont know if this would have detrimental effects on my gym training (i do not currently use juice, only been training natty.) The reason i think this is because of the frequency of the injections against my natural test levels. (i am aware this will cause full shut down)
----------------------------------------
University of Edinburgh / NHS Lothian
PARTICIPANT INFORMATION SHEET
A25165 "Sperm suppression and contraceptive protection provided by
Norethisterone enanthate (Net-En) combined with Testosterone
Undecanoate (TU) in healthy men."
This is a brief version of the Participant Information Leaflet for the study. We
will give you the full version when you attend to discuss the study in detail.
Summary
The overall purpose of this research is to develop a male contraceptive that is safe,
effective and reversible. This particular study investigates whether a combination of
hormones will prevent pregnancy by decreasing your sperm count in a way that is
fully reversed when treatment stops. We will also watch for any side effects (see
section on page 7), and want to know if you like this treatment as a potential future
contraceptive method. The study is organised by the World Health Organisation.
This research requires you to have a series of paired hormone injections, (one into
each buttock), every 8 weeks, this will be between 16-20 injections over a period of
18 month – depending on the time taken for your sperm to suppress. These
injections aim to switch off sperm production. During the study you have to provide a
brief medical history, undergo physical examinations, provide blood, urine and
semen samples and fill out questionnaires. The study is expected to take up to 27
months.
Participant Selection
You have been asked to participate in this study because you are a healthy man,
(aged 18 to 45) who is in a stable relationship with only one woman (aged 18 to 38)
for at least the past year and you both do not wish her to become pregnant within
the next 2 years.
Although the exact risk is unknown, from previous experience and research,
the potential risk of pregnancy during this study is likely to be similar to using
the female oral contraceptive pill. You will only be included in this study if you
accept this possibility of pregnancy
Information on the drugs
The hormones used in this research are, a progestin called norethisterone
enanthate (abbreviated Net-En) and an androgen called testosterone undecanoate
(abbreviated TU). Both hormones have been tested separately and in combination
for sperm suppression in small numbers of healthy men. Bayer Schering Pharma
AG, in Berlin, Germany, manufactures both hormones.
Procedures and Protocol
• Injections will be given to you every 8 weeks,
This research study consists of four phases:
Phase 1 (Screening) (takes 1 - 2 months to check if you are suitable to enter the
study) you will come to the hospital two or three times.
Phase 2 (Suppression) (lasting up to 6 months from start of treatment and checks
if your sperm output can be suppressed to low enough levels for reliable
contraception)
During Phase 2, you and your partner should continue to use an effective method of
contraception. If your partner is using a hormonal contraceptive before the study,
she will have to stop using it soon after you enter Phase 2 and switch to a non-
hormonal barrier method of contraception (condoms, diaphragm) until your sperm
counts are low enough to enter Phase 3 (Contraceptive Efficacy).
Phase 3 (Efficacy) (lasting about 12 months and checks if the hormone
suppression of sperm output prevents pregnancies)
You and your partner will stop using all other methods of contraception.
You will visit the Unit every 8 weeks for study injections, to provide semen and blood
samples, have physical examinations, complete questionnaires and keep a
menstrual diary.
Phase 4 (Recovery) (this may last for up to 8 months, or rarely longer for a few
men and checks to see your sperm output has returned to normal)
In Phase 4, you and your partner are advised to use another reliable
contraceptive method if you wish to avoid a pregnancy.
Possible side effects of TU
The most frequent undesirable effects of treatment with TU, occurring in between
1% and 10% of men in clinical trials, were acne and pain, itching, redness, swelling,
or bruising at the injection site. Other common side effects included weight gain, hot
flushes, a condition in which there is an increase in blood cells in the body, and
changes in the prostate as described below.
Compensation
For each visit, you will be compensated for your travel to the hospital and other
reasonable expenses. However you and your partner will be compensated for your
time, a total of £500, spread across the duration of the study.
