Vaginal Estrogen for Sexual Dysfunction in Breastfeeding Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether vaginal estrogen cream (estradiol) can improve sexual function in breastfeeding new mothers. The study compares this cream's effects to a regular vaginal moisturizer. Women who had a full-term, single baby and plan to breastfeed or pump can participate. They should be between six weeks and six months postpartum and have successfully breastfed or pumped in the past. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients, offering reassurance and potential improvements for participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Studies have shown that vaginal estradiol, a type of estrogen, is generally safe for use after childbirth. Research indicates that patients usually tolerate it well. One study found that local estradiol after childbirth had few side effects and was safe for breastfeeding individuals. Additionally, the FDA has approved estradiol for other uses, supporting its safety. While every treatment can have side effects, current evidence suggests that vaginal estradiol is a safe option for postpartum patients seeking to improve sexual function.12345
Why are researchers enthusiastic about this study treatment?
Most treatments for sexual dysfunction in breastfeeding patients, such as lubricants and moisturizers, focus on providing temporary relief without addressing underlying hormonal changes. Estradiol is unique because it targets hormonal imbalances directly by providing localized estrogen through a vaginal insert. This method could potentially offer longer-lasting relief by restoring natural vaginal function and improving tissue health. Researchers are excited about the potential for estradiol to offer a more sustainable solution compared to conventional options.
What evidence suggests that this trial's treatments could be effective for sexual dysfunction in breastfeeding patients?
Research has shown that vaginal estrogen, specifically estradiol, can improve sexual function for new mothers, particularly those breastfeeding. In this trial, participants will receive either vaginal estrogen or a vaginal moisturizer. One study found that local estradiol provided only a small benefit for symptoms like thinning and irritation of the vaginal walls, but it proved safe and acceptable for use after childbirth. Another analysis found no significant negative effects with low-dose vaginal estradiol, confirming its safety. Overall, despite modest benefits, vaginal estrogen remains a safe option for addressing sexual issues during breastfeeding.25678
Who Is on the Research Team?
Rachel Pope, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Are You a Good Fit for This Trial?
This trial is for postpartum individuals who are at least 18 years old, sexually active, have had a term birth, and plan to breastfeed or pump. They should be between 6 weeks and 6 months postpartum and able to consent in English. Those with preterm delivery, breastfeeding difficulties, estrogen contraindications like cancer or clotting disorders, severe perineal tears, or liver disease cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Baseline Assessment
Participants are randomized into two groups and complete a baseline questionnaire
Treatment
Participants use either vaginal estrogen or moisturizer for 12 weeks
Follow-up
Participants complete follow-up questionnaires at 6 and 12 weeks
Long-term Follow-up
Additional questionnaires administered at 6 months and 1 year to assess long-term benefits
What Are the Treatments Tested in This Trial?
Interventions
- Estradiol
- Vaginal Moisturizer
Estradiol is already approved in European Union, United States, Canada for the following indications:
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
- Moderate to severe vasomotor symptoms due to menopause
- Vulvar and vaginal atrophy due to menopause
- Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
- Prevention of postmenopausal osteoporosis
- Palliative treatment of breast cancer
- Palliative treatment of prostate cancer
- Menopausal symptoms
- Hypoestrogenism
- Osteoporosis prevention
- Breast cancer palliation
- Prostate cancer palliation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor