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?
The purpose of this study is to assess the safety and effectiveness of the Viveve Geneveve Treatment for female sexual dysfunction following vaginal childbirth. Viveve, the study Sponsor, is conducting this study to submit its results to FDA. If approved, the Geneveve Treatment for female sexual dysfunction will be available in the United States.  
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?
Viveve, Inc, a women’s health and wellness company, is the sponsor of this study.  To learn more about the sponsor, visit Viveve.com 
What is the investigational device treatment that is being tested?
The Geneveve Treatment is a single-session, 30-minute procedure completed by a study doctor using the Viveve System.  The study is evaluating the Geneveve Treatment to improve sexual function in women with decreased sexual function following vaginal childbirth.  The vaginal tissue just inside your vagina will be treated using radiofrequency (RF) energy to heat 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.  The Geneveve Treatment does not require any other medicine or treatment prior to the procedure. 
What is the placebo or sham treatment and is there a chance I will receive the placebo treatment?
The placebo treatment (sometimes referred to as ‘sham’) resembles the Geneveve Treatment, but will not emit enough RF energy to elicit a response in the vaginal tissue.  A placebo is used in clinical research studies to determine if the active treatment being evaluated is safer and more effective than no treatment at all.  There is a 50/50 chance you will receive the placebo treatment or active treatment.  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. 
Do I have to pay or need insurance to participate in the VIVEVE II Study?
Medical insurance is not required or necessary for participation in the VIVEVE II Study.  There is no charge for taking part in this research study.  All study related exams, visits and procedures related to the study will be provided at no cost to you. 
Do I need to ask my regular doctor before I can participate in this clinical research study?
No.  While you do not need to ask for permission, it is recommended you discuss with your regular doctor that you are thinking of participating in this study if you want their advice.  Your doctor may wish to contact the study staff (with your permission) to request additional information. 
Will I have to switch doctors?
No. This clinical research study will provide short-term study-related care only. Clinical studies do not provide extended or comprehensive primary health care. Your regular doctor may wish to work with the study team to best determine which treatments or medications are most appropriate for your care. 
Where are the study clinics/centers?
The study clinics are located at 25 centers across the United States and Canada. 
Will I be paid for my time and travel?
Qualified study participants who enroll in the study will be eligible for compensation for their time and travel.  Study staff will discuss compensation with you if you pre-qualify and are referred to a study clinic. 

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?
Clinical Trials, also known as research studies, are studies in which people volunteer to test a new medical treatment or device.  These studies start small, usually involving a small number of patients.  As the data shows support for positive trends, the studies grow larger including more patients, and/or healthy volunteers.  It is with these volunteers that advancement in the diagnosis, treatment and curing of diseases is achieved! 
Who can participate?
All studies have specific criteria that must be met prior to enrollment in studies.  The specific criteria that must be met are called ‘inclusion criteria.’  Protocols also have what is referred to as ‘exclusion criteria’ which, if met by the participant, excludes them from the study.  Eligibility for inclusion in a study can be dependent on a variety of factors, including age, gender, medical history, current treatments, etc.  Some studies may rely on participants having a certain illness or condition to study the effects of a treatment, while other studies may require healthy volunteers.  All criteria are discussed at length and in detail at your first study visit. 
Why should I participate?
Participating in clinical trials allows for specialized medical care with access to new therapies and treatments, at no cost to you!  Insurance is not required, and you may be compensated for time and travel.  In addition, participating allows for the chance to aid in the development and advancement of medical treatments! 
Who Sponsors clinical trials?
Clinical Trials are sponsored by a wide variety of organizations, including but not limited to the government, private pharmaceutical companies, independent research organizations, academic universities and volunteer groups.  Trials may also be sponsored by physicians and medical personnel.  The VIVEVE II Study is sponsored by Viveve, a women’s health and wellness company. 
Where do clinical trials take place?
Trials may take place in a variety of locations, including your doctor’s office, universities, hospitals and community clinics.  The location depends on the study. 
What is informed consent?
Informed Consent is the process by which a study participant (you) willfully volunteers to participate in the study after reviewing the Informed Consent Form (ICF).  Prior to study participation, all volunteers are provided with the ICF for reading and understanding.  The ICF details all study information, including purpose, duration, proposed treatment, visits schedules and procedures, and potential risks and benefits.  After review, time is spent with the study staff or study doctor to discuss the trial and if it’s right for you.  You will be provided ample time to review the consent, ask questions and decide on your own if you want to participate in the study.  If you do, the consent form is signed by you and the study staff.  A signed copy should be provided to you for your records. 
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?
You are free to withdraw from a study at any point in the study.  It is important that you let the study team know the reason for withdrawal, and if possible, an early termination visit should be scheduled to ensure safe exit from the study. 
Is research right for me?
There are many factors that should affect your decision to participate in a trial.  Below are some questions you should take into consideration before deciding to participate:

  • 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.

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