100 Participants Needed

Vaginal Estrogen for Sexual Dysfunction in Breastfeeding Patients

SD
RB
Overseen ByRosemary Brewka
Age: 18 - 65
Sex: Female
Trial Phase: Phase 4
Sponsor: University Hospitals Cleveland Medical Center
Must be taking: Vaginal estrogen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.

Research Team

RP

Rachel Pope, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

History of successful breastfeeding or pumping after a prior pregnancy
I am 18 years old or older.
Not meeting any exclusion criteria
See 5 more

Exclusion Criteria

History of difficulty breastfeeding
I have had a severe tear in the perineal area.
Preterm delivery
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Randomization and Baseline Assessment

Participants are randomized into two groups and complete a baseline questionnaire

1 week
1 visit (virtual)

Treatment

Participants use either vaginal estrogen or moisturizer for 12 weeks

12 weeks
Weekly virtual check-ins

Follow-up

Participants complete follow-up questionnaires at 6 and 12 weeks

4 weeks
2 visits (virtual)

Long-term Follow-up

Additional questionnaires administered at 6 months and 1 year to assess long-term benefits

Up to 1 year

Treatment Details

Interventions

  • Estradiol
  • Vaginal Moisturizer
Trial OverviewThe study tests if vaginal estrogen cream improves sexual function in postpartum patients who breastfeed compared to those using no treatment. Participants will either receive the estradiol cream or a non-medicated vaginal moisturizer to see which is more effective.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Vaginal EstrogenExperimental Treatment1 Intervention
Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
Group II: Vaginal MoisturizerActive Control1 Intervention
Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.

Estradiol is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Estradiol for:
  • Menopausal symptoms
  • Hypoestrogenism
  • Osteoporosis prevention
  • Breast cancer palliation
  • Prostate cancer palliation
πŸ‡ΊπŸ‡Έ
Approved in United States as Estradiol for:
  • 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
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Approved in Canada as Estradiol for:
  • 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

Trials
348
Recruited
394,000+