BreastfeedingPhase 4NCT05457972
Postpartum Vaginal Estrogen for Breastfeeding Patients
A Phase 4 study testing Estradiol and Vaginal Moisturizer in people with Breastfeeding and Postpartum Sexual Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breastfeeding, Postpartum Sexual Dysfunction, Vaginal Atrophy
- What is being tested?
- Estradiol and Vaginal Moisturizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Not meeting any exclusion criteria
Who cannot join
- Preterm delivery
- Perinatal mortality
- History of difficulty breastfeeding
- 3rd 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Susan Wherley, MD, 216-844-1446, susan.wherley@uhhospitals.org
Rosemary Brewka, 216-844-1446, rosemary.brewka@uhhospitals.org
About this study
Official title: Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled 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.
Read the detailed description
This will be a prospective, randomized clinical trial of postpartum breastfeeding patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital will be evaluated for inclusion/exclusion by review of their medical record by the study investigators prior to discharge home. The study will then be discussed with the eligible patients privately. If they agree to participate, informed consent will be obtained. At this time, contact information will be obtained for all consenting patients.
Between 5 and 6 weeks postpartum, all consented patients will be contacted via their preferred form of communication. Inclusion criteria and desire for continued study participation will be verified prior to randomization. A baseline REDCap questionnaire will be texted or emailed to confirmed study participants. UH REDCap is a HIPAA-certified, secure, web-based data storage platform for research studies.
The patient will then 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.
After randomization, but not prior to 6 weeks postpartum, the investigational drug service courier service will deliver softgel inserts of vaginal estrogen to the homes of participants randomized to the estrogen arm. Study investigators will deliver vaginal moisturizer to the homes of participants randomized to the placebo arm. Study participants will be provided with an instructional handout including information about how and how often to use the inserts or the moisturizer. Participants will be instructed to start using the inserts or lubricant when they receive the delivery. This will be considered the start of the study period.
During the study period, participants will use either estrogen or vaginal moisturizer nightly for two weeks and then twice weekly for ten weeks. Each week during the study period, participants will receive a message via their preferred communication method with five questions:
- Did you breastfeed or pump this week?
- Were you sexually active this week?
- If you were sexually active, did you have vaginal pain with sexual activity?
- How many times this week did you use the vaginal insert?
- Did you experience any change in your health this week? 6 and 12 weeks into the study period, the patient will be contacted by their preferred communication method and requested to complete a questionnaire via UH REDCap.
The initial study questionnaire will include questions about demographics, gravidity and parity, prior deliveries (including mode of delivery, obstetric lacerations, and infant feeding), baseline sexual activity, prior pelvic surgery, chronic pain disorders, and plans for infant feeding. The 6 and 12-week study questionnaires will include the FSFI, the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the urinary distress inventory (UDI-6), the vaginal assessment scale (VAS), the Sexual Function Questionnaire Medical Impact Scale (SFQ-MIS), and the Female Sexual Distress Scale-Revised (FSDS-R) as well as questions about sexual activity and plans for infant feeding.
Questionnaire responses will be reviewed by a study investigator after completion by the patient. Any patients whose questionnaires indicate possible depression (EPDS score 10+), thoughts of self-harm (any answer other than "never" on EPDS question 10), or moderate to severe anxiety (GAD-7 score 10+) will be evaluated for safety by a physician study investigator and referred to UH Reproductive Behavioral Health.
In order to assess long term benefits of estrogen therapy in the early postpartum period, additional questionnaires will be administered at 6 months and 1 year to patients. The study intervention period will last 12 weeks, after which no additional vaginal estrogen or vaginal moisturizer will be administered to participants. Patients desiring to continue treatment after the 12-week study intervention period will be referred to their postpartum care provider. Patients will be instructed to stop estrogen use after they have completed breastfeeding.
- Being tested
- Estradiol, Vaginal Moisturizer
- Keywords
- vaginal atrophy, postpartum, sexual dysfunction, dyspareunia, breastfeeding, pumping, vaginal dryness
- Medical subject headings
- Breast Feeding, Sexual Dysfunction, Physiological, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Imvexxy
Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
Vaginal MoisturizerDevice
Also called Carlson Key-E Suppositories
Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Estrogen | Experimental | Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks. Receives: Drug: Estradiol |
| Vaginal Moisturizer | Active comparator | Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks. Receives: Device: Vaginal Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks into study period
Secondary outcomes (9)
Desire as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 1.2-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Arousal as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Lubrication as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Orgasm as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Satisfaction as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0.8-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Pain as measured by Female Sexual Function Index (FSFI)
One out of six FSFI domains. Score range of 0-6, with a higher score indicating better functioning.
Measured: Up to 12 weeks into study period
Intercourse resumption
Number of weeks until resumption of intercourse after delivery
Measured: Up to 12 weeks into study period
Serum estradiol levels
Measured: Up to 12 weeks after study medication initiation
Breast milk estradiol level
Measured: Up to 12 weeks after study medication initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start22 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Pope, University Hospitals Cleveland Medical Center
- Investigators
- Rachel Pope, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457972
- Sponsor's protocol ID
- STUDY20220578
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25565323Banaei 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.
PubMed 30515059Constantine 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.
PubMed 27922936Kahan 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.
PubMed 24755011Krause 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.
PubMed 22453284Matthies 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.
PubMed 30327862McCabe 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.
PubMed 26953829Portman 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.
PubMed 25160739Shifren 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.
PubMed 18978095Suckling 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.
PubMed 17054136Alp 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.
PubMed 31298557
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05457972
- Acronym / sponsor ID
- STUDY20220578
- Keywords
- vaginal atrophy, postpartum, sexual dysfunction, dyspareunia, breastfeeding, pumping, vaginal dryness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a prospective, randomized clinical trial of postpartum breastfeeding patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital will be evaluated for inclusion/exclusion by review of their medical record by the study investigators prior to discharge home. The study will then be discussed with the eligible patients privately. If they agree to participate, informed consent will be obtained. At this time, contact information will be obtained for all consenting patients.
Between 5 and 6 weeks postpartum, all consented patients will be contacted via their preferred form of communication. Inclusion criteria and desire for continued study participation will be verified prior to randomization. A baseline REDCap questionnaire will be texted or emailed to confirmed study participants. UH REDCap is a HIPAA-certified, secure, web-based data storage platform for research studies.
The patient will then 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.
After randomization, but not prior to 6 weeks postpartum, the investigational drug service courier service will deliver softgel inserts of vaginal estrogen to the homes of participants randomized to the estrogen arm. Study investigators will deliver vaginal moisturizer to the homes of participants randomized to the placebo arm. Study participants will be provided with an instructional handout including information about how and how often to use the inserts or the moisturizer. Participants will be instructed to start using the inserts or lubricant when they receive the delivery. This will be considered the start of the study period.
During the study period, participants will use either estrogen or vaginal moisturizer nightly for two weeks and then twice weekly for ten weeks. Each week during the study period, participants will receive a message via their preferred communication method with five questions:
- Did you breastfeed or pump this week?
- Were you sexually active this week?
- If you were sexually active, did you have vaginal pain with sexual activity?
- How many times this week did you use the vaginal insert?
- Did you experience any change in your health this week? 6 and 12 weeks into the study period, the patient will be contacted by their preferred communication method and requested to complete a questionnaire via UH REDCap.
The initial study questionnaire will include questions about demographics, gravidity and parity, prior deliveries (including mode of delivery, obstetric lacerations, and infant feeding), baseline sexual activity, prior pelvic surgery, chronic pain disorders, and plans for infant feeding. The 6 and 12-week study questionnaires will include the FSFI, the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the urinary distress inventory (UDI-6), the vaginal assessment scale (VAS), the Sexual Function Questionnaire Medical Impact Scale (SFQ-MIS), and the Female Sexual Distress Scale-Revised (FSDS-R) as well as questions about sexual activity and plans for infant feeding.
Questionnaire responses will be reviewed by a study investigator after completion by the patient. Any patients whose questionnaires indicate possible depression (EPDS score 10+), thoughts of self-harm (any answer other than "never" on EPDS question 10), or moderate to severe anxiety (GAD-7 score 10+) will be evaluated for safety by a physician study investigator and referred to UH Reproductive Behavioral Health.
In order to assess long term benefits of estrogen therapy in the early postpartum period, additional questionnaires will be administered at 6 months and 1 year to patients. The study intervention period will last 12 weeks, after which no additional vaginal estrogen or vaginal moisturizer will be administered to participants. Patients desiring to continue treatment after the 12-week study intervention period will be referred to their postpartum care provider. Patients will be instructed to stop estrogen use after they have completed breastfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Estrogen | Experimental | Drug: EstradiolEstradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks. |
| Vaginal Moisturizer | Active comparator | Device: Vaginal MoisturizerVaginal moisturizer, daily for two weeks then twice weekly for ten weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Preterm delivery
- Perinatal mortality
- History of difficulty breastfeeding
- 3rd 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstradiolAlso: ImvexxyImvexxy is an FDA-approved drug produced by TherapeuticsMD. | Drug | Vaginal Estrogen |
| Vaginal MoisturizerAlso: Carlson Key-E SuppositoriesIngredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols). | Device | Vaginal Moisturizer |
Primary outcome
Total Female Sexual Function Index (FSFI) score
Time frame: Up to 12 weeks into study period
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.
9 secondary outcomes
Desire as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Arousal as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Lubrication as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Orgasm as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Satisfaction as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Pain as measured by Female Sexual Function Index (FSFI)
Time frame: Up to 12 weeks into study period
Intercourse resumption
Time frame: Up to 12 weeks into study period
Serum estradiol levels
Time frame: Up to 12 weeks after study medication initiation
Breast milk estradiol level
Time frame: Up to 12 weeks after study medication initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 25565323Agarwal 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.
- Background: PubMed 30515059Banaei 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.
- Background: PubMed 27922936Constantine 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.
- Background: PubMed 24755011Kahan 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.
- Background: PubMed 22453284Krause 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.
- Background: PubMed 30327862Matthies 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.
- Background: PubMed 26953829McCabe 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.
- Background: PubMed 25160739Portman 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.
- Background: PubMed 18978095Shifren 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.
- Background: PubMed 17054136Suckling 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.
- Background: PubMed 31298557Alp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Pope, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol and Vaginal Moisturizer in people with Breastfeeding and Postpartum Sexual Dysfunction, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan D Wherley, MD (216-844-1446, susan.wherley@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Female Sexual Function Index (FSFI) score (time frame: Up to 12 weeks into study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457972, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.