Postpartum Vaginal Estrogen for Breastfeeding Patients

NCT05457972 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: STUDY20220578
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Postpartum Sexual Dysfunction; Vaginal Atrophy

Keywords

vaginal atrophy; postpartum; sexual dysfunction; dyspareunia; breastfeeding; pumping; vaginal dryness

Outcome Measures

Primary Outcomes (1)

• Total Female Sexual Function Index (FSFI) score

  Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. A score of 26 has been validated as a threshold for diagnosing female sexual dysfunction.

  Up to 12 weeks into study period

Secondary Outcomes (7)

• Desire as measured by Female Sexual Function Index (FSFI)

  Up to 12 weeks into study period

• Arousal as measured by Female Sexual Function Index (FSFI)

  Up to 12 weeks into study period

• Lubrication as measured by Female Sexual Function Index (FSFI)

  Up to 12 weeks into study period

• Orgasm as measured by Female Sexual Function Index (FSFI)

  Up to 12 weeks into study period

• Satisfaction as measured by Female Sexual Function Index (FSFI)

  Up to 12 weeks into study period

Study Arms (2)

Vaginal Estrogen

EXPERIMENTAL

Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.

Drug: Estradiol

Vaginal Moisturizer

ACTIVE COMPARATOR

Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.

Device: Vaginal Moisturizer

Interventions

Estradiol DRUG

Imvexxy is an FDA-approved drug produced by TherapeuticsMD.

Also known as: Imvexxy

Vaginal Estrogen

Vaginal Moisturizer DEVICE

Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).

Also known as: Carlson Key-E Suppositories

Vaginal Moisturizer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 or older
• Sexually active
• Singleton, term (37 weeks 0 days) birth
• Planning to breastfeed or pump during the study period
• History of successful breastfeeding or pumping after a prior pregnancy
• Between 6 weeks and 6 months postpartum (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)
• Ability to consent in English

You may not qualify if:

• Preterm delivery
• Perinatal mortality
• History of difficulty breastfeeding
• rd or 4th degree perineal laceration
• Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)/pulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (11)

• Agarwal SK, Kim J, Korst LM, Hughes CL. Application of the estrogen threshold hypothesis to the physiologic hypoestrogenemia of lactation. Breastfeed Med. 2015 Mar;10(2):77-83. doi: 10.1089/bfm.2014.0030. Epub 2015 Jan 7.

  PMID: 25565323 BACKGROUND

• Banaei M, Moridi A, Dashti S. Sexual Dysfunction and its Associated Factors After Delivery: Longitudinal Study in Iranian Women. Mater Sociomed. 2018 Oct;30(3):198-203. doi: 10.5455/msm.2018.30.198-203.

  PMID: 30515059 BACKGROUND

• Constantine GD, Simon JA, Pickar JH, Archer DF, Kushner H, Bernick B, Gasper G, Graham S, Mirkin S; REJOICE Study Group. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. Menopause. 2017 Apr;24(4):409-416. doi: 10.1097/GME.0000000000000786.

  PMID: 27922936 BACKGROUND

• Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014 Apr 23;15:139. doi: 10.1186/1745-6215-15-139.

  PMID: 24755011 BACKGROUND

• Krause M, Wheeler TL 2nd, Richter HE, Snyder TE. Systemic effects of vaginally administered estrogen therapy: a review. Female Pelvic Med Reconstr Surg. 2010 May;16(3):188-95. doi: 10.1097/SPV.0b013e3181d7e86e.

  PMID: 22453284 BACKGROUND

• Matthies LM, Wallwiener M, Sohn C, Reck C, Muller M, Wallwiener S. The influence of partnership quality and breastfeeding on postpartum female sexual function. Arch Gynecol Obstet. 2019 Jan;299(1):69-77. doi: 10.1007/s00404-018-4925-z. Epub 2018 Oct 16.

  PMID: 30327862 BACKGROUND

• McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Segraves RT. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52. doi: 10.1016/j.jsxm.2015.12.034.

  PMID: 26953829 BACKGROUND

• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329.

  PMID: 25160739 BACKGROUND

• Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008 Nov;112(5):970-8. doi: 10.1097/AOG.0b013e3181898cdb.

  PMID: 18978095 BACKGROUND

• Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500. doi: 10.1002/14651858.CD001500.pub2.

  PMID: 17054136 BACKGROUND

• Alp Yilmaz F, Sener Taplak A, Polat S. Breastfeeding and Sexual Activity and Sexual Quality in Postpartum Women. Breastfeed Med. 2019 Oct;14(8):587-591. doi: 10.1089/bfm.2018.0249. Epub 2019 Jul 12.

  PMID: 31298557 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Sexual Dysfunction, Physiological; Dyspareunia

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Rachel Pope, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan D Wherley, MD

CONTACT

216-844-1446; susan.wherley@uhhospitals.org

Rosemary Brewka

CONTACT

216-844-1446; rosemary.brewka@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio into two study groups: vaginal estrogen or vaginal moisturizer. Randomization will be performed using blocking with a block size of 10 and a 1:1 allocation ratio. The randomization sequence will be generated using a random number table.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: February 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)