Research

ENACT: National Institutes of Health National Centers for Translational Research in Reproduction and Infertility Endometrial Tissue and DNA Bank at UCSF

This study is a collaboration between the Division of Gynecology at Stanford Medicine and UCSF's Gynecology Division. The purpose of this study is to collect, store, and distribute endometrial tissues and DNA samples for use in female fertility research. Researchers involved in the study hope that this comprehensive examination of the basic biology of the endometrium will aid in explaining both normal reproduction and reproductive disorders. Implantation, endometrial growth, angiogenesis, normal menstruation, abnormal uterine bleeding, and endometriosis are all aspects of reproductive health that researchers hope to gain insight on through this P01 study.

ENACT is enrolling people under the age of 45 who have regular menses, are not currently using hormonal birth control, and are undergoing hysterectomies, hysteroscopies, and laparoscopies at Stanford for reasons other than pelvic cancer diagnosis. Participants will be asked for consent to collect a blood draw before their procedure and an endometrial biopsy during the procedure. All study procedures will be completed on the day of the participant’s surgery – no follow-up visits are required of the participant. To learn more about the ENACT program, click here.

Principal Investigator: Brice Gaudillière, MD, PhD

DYAD: Chronic disease, the adolescent-parent dyad, and contraception: a mixed-methods study

This study is a mixed-methods study that seeks to interview adolescents with chronic illnesses and their parents. The interviews (conducted by doctors involved in the study) will explore three topics: how the parent and adolescent co-manage the disease; how the parent and adolescent understand the adolescent’s reproductive health; and how contraception has been a part of their medical care up to this point. These individual interviews would be conducted virtually over Zoom and would last between 45-60 minutes.

The DYAD study is actively enrolling adolescents between the ages of 15-20 with either cystic fibrosis, a congenital heart disease, or those who have had a solid organ transplant before the age of 8. Participation would only require individual interviews with both the adolescent and the parent in the dyad.

Principal Investigator: Nichole Tyson, MD

Luminous: A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety

The objective of this study is to assess the contraceptive efficacy of an investigational new drug – a new formulation of a hormonal birth control patch. This new formulation is a lower dose of estrogen, which is expected to be comparable in effectiveness in controlling pregnancy to Combined Oral Contraceptives (COCs). With this lower dose of estrogen, this patch aims to provide an improved safety profile as compared to the standard higher dose of estrogen commonly found in hormonal birth controls. 

This study is enrolling healthy participants who are of childbearing potential and are over the age of 16 to assess how this birth control patch performs over a period of thirteen 28-day cycles. As such, participation in the study is expected to last up to 13 months. Throughout this time, participants in the study will be asked to use the new birth control patch as their sole form of contraception for the entire duration of the study. Study participants will record these 28-day cycles of patch use in an electronic diary to determine whether a participant was at risk for pregnancy over the course of the 13 cycles. Participants will also be requested to come in for four in-person clinic visits for assessment from a physician and are expected to receive nine telephone follow-up visits. At each clinic visit, the health of the participants will be assessed by a provider and an examination for pregnancy will be performed.

Principal Investigator: Paul Blumenthal, MD, MPH

SERENE: A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women with Uterine Fibroids or Endometriosis Who Are 16 to 50 Years of Age and at Risk for Pregnancy

The SERENE study aims to learn more about the safety and efficacy of a study birth control pill to prevent pregnancy in people with endometriosis or uterine fibroids. Relugolix, the study drug, is an FDA-approved medication commonly prescribed for the management of endometriosis and uterine fibroids. However, it is a combination therapy medication and, as such, is often not offered for use to people who are currently managing their diagnosis with hormonal birth control. Many people with either endometriosis or uterine fibroids are offered alternative methods of birth control. However, because of its mechanism of action in the body, it may be that Relugolix can serve a dual purpose of management of these uterine bleeding disorders and contraception. 

This study is actively enrolling people between the ages of 18-50 who have been diagnosed with endometriosis or uterine fibroids and are at risk for pregnancy. Participants in the study will be asked to take the study drug, Relugolix, orally once daily for a year and use this drug as the only form of contraception for the entirety of the study. Participants will also be asked to complete a series of study visits: ten office visits, four follow-up phone calls, and two in-person visits one year post-treatment. These in-person visits will include physical exams, lab tests, bone density scans, and other examinations to ensure patient health. 

Principal Investigator: Paul Blumenthal, MD, MPH

FINALE: Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control

The objective of this study is to evaluate the contraceptive efficacy of the FemBloc permanent birth control method. FemBloc is a non-surgical permanent birth control system that delivers a biopolymer to occlude the fallopian tubes during an in-office procedure. The delivered polymer eventually degrades over time and causes permanent sterilization. The polymer is then repeatedly assessed to determine whether the birth control system was effective in permanently occluding the fallopian tubes. The FemBloc system aims to be a permanent birth control method that avoids all the risks of surgical procedures and provides more accurate documentation of bilateral occlusion of the Fallopian tubes.

The FINALE study will be recruiting participants between the ages of 21-50 years old with regular menses who are at risk of pregnancy and desire permanent birth control. Participants must also be willing to use temporary birth control until complete occlusion is documented. However, after the occlusion is documented, the FemBloc permanent birth control will be assessed as the sole contraceptive used by participants. Participation in the study would last about five and a half years, consisting of three to four in-person visits and six to seven follow-up visits. Most of the follow-up visits will be conducted over the phone yearly to assess participant health and reliance on FemBloc for birth control. The in-person visits would consist of assessment of the participant's health, usage of the FemBloc system, and documentation of complete occlusion. 

Principal Investigator: Erica P. Cahill, MD, MS(c)

M360-IRD: Clinical Testing of an Intrauterine Contraceptive Removal Device

This study aims to assess the performance of a novel intrauterine contraceptive removal device when used by healthcare professionals to remove an intrauterine device (IUD). This device aims to find a way to increase the number of physicians that can perform in-office IUD removals by standardizing the procedure as much as possible, in the hopes that this can eventually be done by IUD users themselves. 

This study will be recruiting individuals over the age of 18 who desire IUD removal for a reason other than medical anomaly. Participants will only be required to complete their in-office IUD removal, as well as one telephone follow-up visit to assess how they have recovered after the removal is complete. They will also be asked about their opinion concerning the removal device. 

Principal Investigator: Kate Shaw, MD, MS

LevoCept: A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate Levocept®, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability

The primary objective of this study is to assess the efficacy of LevoCept in preventing pregnancy for participants who are at risk of pregnancy over the course of five years. LevoCept is a hormonal IUD with a hormonal reservoir comparable to MIRENA and LILETTA, and releases hormones at a similar rate over its lifetime. While LevoCept’s formula is not unique, its construction is a little different from other intrauterine devices on the market. It is preloaded into its introducer at the time of manufacturing, allowing for less handling and potential for contamination at the time of introduction into the uterus. The tip of the introducer is also able to be tapered in such a way that aims to reduce insertion pain, along with hopefully reducing the need to manually dilate the cervix for insertion. 

The LevoCept study will be recruiting participants under the age of 45 who are at risk of pregnancy, desire long-term intrauterine contraceptive for birth control, and have a history of regular menses without the use of hormonal birth control. Both parous and nulliparous people are eligible to participate in the study. Participants must be willing to use LevoCept as their sole form of contraception for the duration of the study. Participants will be asked to come in for twelve in-person office visits to assess their health while using LevoCept and respond to twenty-seven phone calls over the course of the five-year study. 

Principal Investigator: Paul Blumenthal, MD, MPH

CELLEBRATE: An Adaptive, Two Stage, Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence

The purpose of this study is to evaluate the safety and efficacy of muscle derived cells for bladder opening repair. Muscle cells will be harvested by thigh muscle biopsy from patients who suffer from stress urinary incontinence and have previously undergone surgery for the treatment of their stress urinary incontinence. The participant’s cells will be expanded in culture until there is an adequate number of cells. Participants would then be randomized to one of two blinded groups: treatment or placebo. Once they are randomized, they will receive an injection of either the cells or the placebo into their bladder opening. Their health would be monitored for up to two and a half years post-injection to see whether the product is a safe and effective treatment for recurrent stress urinary incontinence.

This study is actively recruiting women over the age of 18 who suffer from stress urinary incontinence and have previously had surgery specifically to correct their stress incontinence. Participants would be asked to come in for between eight to eleven in-person visits and respond to three to five follow-up telephone calls over the course of two and a half years. The numbers of visits and telephone follow-ups depend on whether participants received their own treatment cells or the placebo. If participants are unblinded and find they received the placebo, they can make the decision one year post-injection to receive their cells. At this point, they would go through the same follow-up appointments to ensure the efficacy and safety of the study product.

Study visits would include monitoring of the participant’s urinary incontinence (whether it has improved or not) and monitoring of the participant’s overall health. Participants would receive a urogenital examination, a physical exam, a post-void residual volume check, and a cystourethroscopy per each study visit. Questionnaires and other information would also be collected from participants at this time.

Principal Investigator: Eric Sokol, MD

TheraNova: Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

The purpose of this study is to evaluate the safety and efficacy of the TheraNova Neuromodulation System at decreasing symptoms related to overactive bladder (OAB). The TheraNova Neuromodulation System aims to be a non-invasive treatment akin to a TENS unit so that patients can self-administer 30-minute treatments for relief of OAB symptoms. This would provide an alternative to people with OAB who are unable to take medication or receive more invasive procedures. 

Study enrollment has paused but will resume in fall 2023 and be open to adult women who suffer from overactive bladder (OAB) with urge urinary incontinence or mixed urinary incontinence. Participants would be asked to self-administer one 30-minute treatment three times per week for the duration of the study (12 weeks in total). 

Principal Investigator: Eric Sokol, MD

TRIUMPH: Treating Incontinence for Underlying Mental and Physical Health

The objective of this study is to compare the effects, good and bad, of two commonly prescribed medications for urge urinary incontinence. The medications in question are mirabegron (Myrbetriq) and tolterodine (Detrol). Participants will be randomized to one of three blind participant groups: the placebo, mirabegron, or tolterodine tartrate. Over the course of nine months, they will complete a variety of physical and cognitive assessments and questionnaires about their emotional health to gain a better understanding of how these treatment options affect the overall quality of life of study participants. 

The study is recruiting participants who are over the age of 60 with urge incontinence who experience more than one urge leak per week. Participants will be asked to come in for five in-person visits and respond to two telephone follow-up visits. Participants also have the option of completing some of their in-person visits remotely, over Zoom. In addition to cognitive assessments, questionnaires, and physical assessments, participants will also be asked to complete 7-day diaries prior to all study visits. The study duration for each participant will be nine months in total: six of those months will be medicated, and the remaining three months will be unmedicated. 

Principal Investigator: Leslee Subak, MD

EVANESCE-II: Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

In this study, a new device called FemPulse will be compared to a tolterodine, a standard medication treatment for overactive bladder, to assess its efficacy for the treatment of overactive bladder. The FemPulse OAB Therapy is composed of a vaginal ring with electrodes to provide mild electrical impulses to the surrounding tissues, a charging station, a remote control for adjustment of the product parameters, and a clinician programmer for programming the simulation parameters. This study aims to determine whether the FemPulse insert is an appropriate treatment for people with mild to moderate OAB. The researchers involved in the study hope to provide alternatives for people who are unable to take medication for their OAB. 

The EVANESCE-II study is recruiting participants who are over the age of 21 and have been diagnosed with overactive bladder for more than 6 months. Participants must be candidates for tolterodine. Participants also must be either completely naïve to OAB medication or be off OAB medications for six months prior to screening for study enrollment. 

Participants would be asked to follow study procedures for different amounts of time depending on which arm of the study they are randomized to. For participants enrolled in the device arm, they would be followed for approximately 12 months after the randomization. They would be asked to come in for 4 in-person visits and respond to 6 calls. For participants randomized to the medication arm, participation in the study could last between 7 to 18 months. This extension is because participants enrolled in the medication arm can choose to transition to the device arm after their participation in the medication arm is complete. These participants on medication would be asked to come in for 3 in-person visits and respond to 5 phone calls for the medication arm alone. After this, if they choose to transition to the device arm, they will follow all device arm study procedures. 

Principal Investigator: Eric Sokol, MD