Characteristics of the study
For ease of reference: A SummaryStudy Protocol
EMPOWER Baseline Questionnaire
EMPOWER Follow-up Questionnaire
Dear colleague,
We would like to ask you for your cooperation in a drug-safety monitoring study in women that need hormone therapy after oophorectomy and hysterectomy. This study is done in agreement with the pharmaceutical company (Procter&Gamble) that produces a testosterone patch which has been approved in this indication. The methodology has been agreed with the European regulatory authorities (in particular the Pharmacoviglance Working Party) in which the British authority (MHRA) is represented.
The abrupt change of estrogen and testosterone levels after a surgically induced menopause has significant consequences for the women concerned. Apart from the typical menopausal symptoms there is frequently loss of libido with a reduction of sexual thoughts, fantasies, and libidinous feelings. This lowered sexuality and the subsequently reduced sexual activity may have a negative impact on self-esteem and the quality of relationships, leading to psychosocial distress and suffering. The causal role of declining testosterone production and the therapeutic value of testosterone substitution has been demonstrated before in individual cases. Regulatory approval of a transdermal patch (Intrinsa) has only been granted recently by the European regulatory authorities after extensive clinical trials. The system delivers 300 micrograms of testosterone per day, i.e. a dose that is adapted to the physiological needs of women.Whilst the large studies for the regulatory process have demonstrated that the patch is efficacious, well tolerated and appears safe, some questions regarding long-term safety can only be answered when the drug is in general use, i.e. after marketing authorization. This is particularly true for diseases of the cardiovascular system and the breast. The company and the European regulatory authorities have established a comprehensive risk management plan. We kindly ask for your help in the present study, which is a crucial component of this program.
This is a controlled prospective long-term non-interventional study. All eligible women are ovarectomised and hysterectomised, in concordance with the approved indication for Intrinsa. Women on estrogen replacement therapy are compared with women who are additionally treated with the Intrinsa testosterone patch.
There is no interference with the decision on the type of hormone replacement (estrogen only or estrogen plus testosterone) or any other therapeutic or diagnostic decisions. At the beginning of the study we ask you for a brief documentation of the patient’s status. Later the Berlin Center for Epidemiology and Health Research (ZEG) and its cooperating organization in the UK - Medicys - will keep contact with the patients and document the follow-up. That means that your only involvement in this study will be to identify relevant women commencing treatment (either Estrogen or Estrogen + Testosterone), inform them about the study, obtain consent and pass on their details to Medicys. All further follow up will be done by Medcys or ZEG. For this you will be reimbursed £70.
For ease of reference: A SummaryWhich women can be included in the study?
- Women with bilateral ovarectomy and hysterectomy.
- Starters and switchers, regardless of previous treatment, on receiving a new prescription. Hormone Replacement
Treatment may consist either of estrogen alone or of estrogen and Intrinsa testosterone patch (indication Hypoactive Sexual
Desire Disorder, HSDD).
What will be the role of your office?
- Asking eligible women to participate, inform and obtain consent, and hand over the study materials (Patient Information, Informed Consent, Information on Data-Protection, Baseline Questionnaire, Contact Information).
- Document the prescribed medications and the reasons for the prescription. Send the completed Informed Consent Form and the
baseline questionnaire to the local operative partner.
- All other logistic problems will be handled by Medicys. Very occasionally, there may be questions regarding the validation of possible serious adverse events.
What will the participating women have to do?
- Sign the Informed Consent form.
- Fill out the baseline questionnaire during the visit.
- Answer follow-up questionnaires over a period of up to 8 years. Questionnaires will be sent to the patient’s home address with a small incentive and with prepaid envelope.
- Answer questions regarding clarification of reported outcomes (preferably by telephone contact)
This international long-term active surveillance study, carefully designed in cooperation with the Regulatory Agencies, will yield valuable data on the safety of hormone replacement in surgical menopause, and will support responsible evidence-based therapy.We hope you will be willing to participate and we look forward to working together with you.
Dr. Juergen Dinger
Director
Berlin Center for Epidemiology
and Health ResearchDr. Timothy Hillard
Consultant Gynaecologist
Poole Hospital NHS Foundation Trust
Poole, Dorset
To open this document, click on the left mouse key. To download it, click on the right.
EMPOWER Baseline QuestionnaireTo open this document, click on the left mouse key. To download it, click on the right.
EMPOWER Baseline Questionnaire
EMPOWER Follow-up QuestionnaireTo open this document, click on the left mouse key. To download it, click on the right.
