Has sex changed
since having kids?
See if you pre-qualify for this clinical research study.
The information you provide is completely confidential and will only be disclosed with your permission except as required by law. If you pre-qualify, your answers will be submitted to the study team to discuss your possible participation.
The VIVEVE II study is testing the safety and effectiveness of the Geneveve Treatment, a new treatment for women having decreased sexual experiences, including satisfaction and pleasure, following vaginal childbirth.
The Geneveve Treatment is available in many countries for the improvement of sexual function, however it is not currently cleared in the United States for female sexual function.
The VIVEVE II Study
The VIVEVE II study is being conducted to evaluate the Geneveve Treatment as a new investigational treatment for women who are having decreased sexual experiences following childbirth, including problems with arousal, desire, lubrication, satisfaction, orgasm and pain during sex.
The anatomical changes that occur to the pelvis and vaginal tissues during childbirth can have a lasting impact on a woman’s sex life. She may experience changes in her sexual desire/interest, sexual excitement/arousal, or her orgasm response (orgasms maybe be weaker than they used to be or may take longer time to achieve them). She may also report pain during or after sex, changes in her overall sexual pleasure/satisfaction or report less vaginal lubrication).
The Geneveve Treatment is a single-session, 30-minute treatment performed by a study doctor in an outpatient setting. During the treatment procedure, the tissue just inside your vagina will be treated using radiofrequency (RF) energy to heat the vaginal tissue, while using a surface coolant to protect the treated tissue. It stimulates your body to produce and strengthen collagen, which helps to stabilize the structures involved with a woman’s sexual function, such as the clitoris and associated structures.
Although this research study is evaluating the Geneveve Treatment, there is an equal chance you may receive a placebo treatment instead of the active Geneveve treatment procedure. The placebo treatment procedure resembles the active treatment procedure in every way but does not provide enough energy to elicit a change in the tissue. This study is randomized and blinded, meaning assignment to a treatment is random and neither you nor the study doctor will know which treatment you receive.
This research study will be conducted at a hospital, research center, or a designated doctor’s office. After you pre-qualify, the study staff will discuss additional details such as study duration, location, number of visits involved, and help answer any questions you may have. As a study participant, all study procedures and tests will be completed at no cost to you.
You may qualify to participate if you:
- Are a premenopausal woman 18 years of age or older
- Have experienced noticeable changes in sexual function since giving birth, including changes in arousal, desire, lubrication, orgasm, pain and satisfaction
- Are not pregnant or actively trying to get pregnant
- Do not have any implantable electrical devices
Deciding to participate in a clinical research study is a complex and personal decision. If you are unsure and want to learn more about the value of participating in clinical research studies, you can visit our About Clinical Research section to learn more.
If you join this study, you will need to be willing and able to visit your doctor more often than would be necessary if you were not in the study. You will be asked to complete 8 scheduled study visits during the approximately 12 months that you will participate in the study.
Approximately 250 women participants are expected to join the VIVEVE II Study at approximately 25 study centers in the United States and Canada.
Qualified participants may receive:
- Geneveve Treatment or placebo treatment at no cost
- Compensation for time and travel
- Study related care from a board-certified physician at no cost
Take the Study Pre-Screener to find out whether you may be eligible to take part in the VIVEVE II study. Other study requirements will be assessed by the study staff.
Compensation for time and travel may be available to you
The information you provide is completely confidential and will only be disclosed with your permission except as required by law. If you pre-qualify, your answers will be submitted to the study team to discuss your possible participation.
You don’t need to have medical insurance to take part
Geneveve is being evaluated as a treatment for women who are having decreased sexual experiences after childbirth, including problems with arousal, desire, lubrication, orgasm and pain during sex.
F.A.Q.’s – VIVEVE II Study
What is the purpose of this study?
What is female sexual dysfunction and how will I know whether I am eligible for the VIVEVE II Study?
- Female sexual dysfunction is a medical condition that is characterized with problems in the female’s sexual response cycle. A woman may experience changes in her sexual desire/interest, sexual excitement/arousal, or her orgasm response (orgasms maybe be weaker than they used to be or may take longer time to achieve them). She may also report pain during or after sex, changes in her overall sexual pleasure/satisfaction or report less vaginal lubrication).
- Many women who had normal sexual function issues, may experience dramatic decreases in sexual satisfaction or pleasure following vaginal childbirth. These sexual changes may be due to the anatomical changes that occur in the pelvic and vaginal tissues during childbirth.
- If you meet the basic criteria for the VIVEVE II Study, you will select a center nearest your location. The staff at the study clinic will contact you and confidentially discuss some of the study details in more depth. The staff at the study clinic may ask you some medical questions about your general health history and other criteria, to see if you meet the criteria to participate in this study.
Who is the sponsor of this study?
What is the investigational device treatment that is being tested?
What is the placebo or sham treatment and is there a chance I will receive the placebo treatment?
Do I have to pay or need insurance to participate in the VIVEVE II Study?
Do I need to ask my regular doctor before I can participate in this clinical research study?
Will I have to switch doctors?
Where are the study clinics/centers?
Will I be paid for my time and travel?
The information you provide is completely confidential and will only be disclosed with your permission except as required by law. If you pre-qualify, your answers will be submitted to the study team to discuss your possible participation.
Geneveve is being evaluated as a treatment for women who are having decreased sexual experiences after childbirth, including problems with arousal, desire, lubrication, orgasm and pain during sex.
About Clinical Research
What are clinical trials or research studies?
Who can participate?
Why should I participate?
Who Sponsors clinical trials?
Where do clinical trials take place?
What is informed consent?
What are the types of clinical trials?
- Interventional studies focus on providing participants with certain interventions. These interventions may be new medications or devices, but they may also include changes to diet or exercise. Sometimes, they may even compare treatments or devices.
- In Observational studies, the focus is on the health outcome of groups of participants according to a research plan or protocol. Participants may receive interventions (including a new medication or treatment), but participants are not specifically assigned an intervention (as in Interventional Studies).
Can I leave a clinical trial after it’s started?
Is research right for me?
- What is the purpose of the study?
- How long will I be in the study?
- Who else is in the study?
- How do the risks, side effects and benefits compare with my current treatment or approved therapy?
- Who will know which intervention I receive in the study? Will I know?
- Are hospital visits required?
- Who will oversee my care?
- Will my study data be provided to me?
- Will I be reimbursed for time and travel?
- Is there a chance I may receive a placebo/sham (substance with no therapeutic effect)?
- What type of long term follow up care is provided?
- If success is found with the study treatment, will I have access to it after study completion?
The information you provide is completely confidential and will only be disclosed with your permission except as required by law. If you pre-qualify, your answers will be submitted to the study team to discuss your possible participation.