What effect does testosterone gel have on female steroid levels?
| ISRCTN | ISRCTN10122130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10122130 |
| Protocol serial number | 2018-02106 |
| Sponsor | Research and Expertise in antiDoping sciences - Université de Lausanne |
| Funder | World Anti-Doping Agency |
- Submission date
- 09/01/2019
- Registration date
- 11/01/2019
- Last edited
- 31/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
In the context of sport, steroids, principally testosterone, are the most used drugs for doping. However, since it is also a molecule produced by our own body, its detection is challenging and therefore requires new detection method development. In addition, the off-label use of clinical testosterone in women is increasing for the treatment of low libido. However, there is little information on the woman's metabolism response resulting from testosterone administration. This study should allow us to know to what extent the administration of transdermal testosterone influences the steroidal profile (blood and urine) of the healthy woman. Indeed, this route of administration is recognized to be the most frequently used for doping purposes.
Who can participate?
Healthy women, aged between 20 and 40 years, and not using hormonal contraception will be recruited for this study.
What does the study involve?
The study is an open-label trial, in which all participants will receive the same treatment. The study takes place over a period of 12 weeks divided into three main phases. Each phase corresponds to a menstrual cycle. The first phase is a follow-up phase during which no treatment is administered but with regular blood and urine collections to establish a baseline. It corresponds to the control phase. The second phase is that of intervention during which a testosterone gel (Tostran) will be applied daily (28 days) on the skin (abdomen and inner thighs) of the volunteers. The daily dose will be 0.5 g of gel corresponding to 10 mg of testosterone administered. Tostran is a testosterone gel approved and marketed in Switzerland. It is used in the substitution treatment of testosterone in adult men during various health problems caused by a deficiency of testosterone (male hypogonadism). The blood and urine samples are collected as in phase I. This phase is followed by phase III, called post-treatment, which is similar to phase I. No intervention is administered and only urine and blood samples are collected.
What are the possible benefits and risks of participating?
Participation in the study is a help for the fight against doping and for the improvement of female metabolism comprehension. The most frequently reported side effects linked to Tostran administration are local skin reactions due to the presence of butylhydoxytoluene (E321) in the drug. It also happens that a long-term treatment causes swelling of the hands and / or feet, hair loss, hypertension, increased body hair, impaired biological balance, cutaneous hypersensitivity, acne , and oily skin.
Since the doses administered will be 6 times lower than those recommended for substitution treatment in humans, these adverse effects will be limited.
Where is the study run from?
This pilot study is conducted only in Switzerland, in Lausanne at the Centre Hospitalier Universitaire Vaudois (CHUV).
When is the study starting and how long is it expected to run for?
The study is supposed to start 01/03/2019 and will last approximately until 31/10/2019.
Who is funding the study?
The World Anti-Doping Agency (WADA).
Who is the main contact?
Martial Saugy
martial.saugy@unil.ch
Contact information
Public
ISSUL - Institut des Sciences du Sports
Syntahlon - Quartier Centre
Lausanne
1015
Switzerland
 ORCID ID |
0000-0003-0388-1352 |
|---|
Scientific
ISSUL - Institut des Sciences du Sports
Synathlon - Quartier Centre
Lausanne
1015
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre open-label trial |
| Secondary study design | Open-label trial |
| Study type | Participant information sheet |
| Scientific title | Establishment of the female steroid profile and impact of transdermal testosterone administration on the steroidal metabolism: open-label trial |
| Study acronym | TestoFem |
| Study objectives | Transdermal testosterone administration influences the female steroid metabolism. |
| Ethics approval(s) | Approved 04/06/2019, Canton de Vaud Human Research Ethics Commission (Av de Chailly 23, 1012 Lausanne, Switzerland; +41 213161830; Secretariat.CER@vd.ch), ref: 2018-02106 |
| Health condition(s) or problem(s) studied | Steroid metabolism |
| Intervention | The trial is an open-label trial which means that every participant will receive the treatment and will know what is the treatment. A treatment with testosterone gel will be administered for 28 days. The product used for the study is Tostran 20 mg/g and 0.5 g of the product corresponding to 10 mg of testosterone will be applied daily on the skin of participants. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tostran (testosterone gel) |
| Primary outcome measure(s) |
Serum testosterone concentration will be measured using UHPLC-MS/MS during the whole study. |
| Key secondary outcome measure(s) |
1. Urinary and serum steroid profile with GC-MS and UHPLC-MS/MS before, during and after treatment. |
| Completion date | 06/08/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 14 |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Female 2. Aged 20-40 years old 3. Body mass index between 18 and 30 kg/m2 4. Hemoglobin concentration between 12 and 16 g/dL 5. Negative pregnancy test at screening 6. Basal testosterone concentration ≤ 1.5 nmol/L 7. Regular menstrual cycles (26-32 days) 8. Normal biological balance (complete blood count, liver function (ASAT / ALAT), CRP, renal function (creatinine)) 9. Normal hormone balance (LH, FSH, SHBG, cortisol, prolactin) |
| Key exclusion criteria | 1. Hypertension (SBP> 140 and DBP> 90 mmHg) 2. Regular intake of tobacco (max 1 cigarette / day) or alcohol (max 1 drink / week) 3. Regular intake of anabolic or ergogenic drugs 4. Holder of a license in a sports discipline 5. Current acne or hirsutism deemed clinically significant 6. Dyslipidemia or hypercholesterolemia 7. Hyperprolactinaemia 8. Endocrine or metabolic disease 9. Tumor of pituitary gland or hypothalamus 10. Contraindications to the class of the substance administered (hypersensitivity or allergy to the active substance or to any of the excipients) 11. Treatment with synthetic anti-thyroid or thyroid hormones 12. Treatment with ketoconazole, anticoagulants, ACTH, corticosteroids 13. Cardiovascular, hepatic, renal or biliary disease 14. Current use of hormonal contraceptives or during the two months preceding the study 15. Pregnancy present or envisaged within 6 months after the end of the study 16. Breastfeeding 17. Eating disorders 18. Previous participation in another study in the last 30 days 19. Sports competition scheduled within 9 months after the end of the study 20. Donation of blood during the last 3 months 21. Migraine 22. Neoplasia or history of neoplasia |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Lausanne
1011
Switzerland
Lausanne
1011
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/05/2021 | Yes | No | ||
| Results article | 29/03/2025 | 31/03/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2025: Publication reference added.
11/05/2021: Publication reference and total final enrolment number added.
06/08/2020: The overall end date was changed from 31/08/2020 to 06/08/2020.
12/06/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2020 to 31/08/2020.
2. The intention to publish date was changed from 31/12/2021 to 31/05/2021.
08/04/2020: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2020 to 31/05/2020.
2. The total final enrolment number has been added.
06/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2019 to 31/03/2020.
2. The intention to publish date was changed from 01/01/2020 to 31/12/2021.
22/07/2019: The ethics approval field has been changed.
22/07/2019: Trial's existence confirmed by SwissMedic.
