Hypoactive Sexual Desire DisorderNCT02859285
A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
A study testing Estradiol vulvar cream in people with Hypoactive Sexual Desire Disorder, run by ProHealth Care, Inc at 1 site in United States.
Trial summary
The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Estradiol vulvar cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction
Who cannot join
- Not sexually active with a partner or an arousal device
- Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
- Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
- Allergic to estradiol
- Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
- Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Waukesa Memorial Hospital
Waukesha, Wisconsin, 53188
About this study
Official title: Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Placebo vulvar cream, Estradiol vulvar cream
- Keywords
- Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal
- Medical subject headings
- Sexual Dysfunctions, Psychological, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo vulvar creamOther
Estradiol vulvar creamOther
| Study group | Role | What they receive |
|---|---|---|
| Estradiol vulvar cream | Active comparator | The estradiol cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks.
In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. Receives: Other: Estradiol vulvar cream |
| Placebo cream | Placebo comparator | The placebo cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks.
In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. Receives: Other: Placebo vulvar cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
19 point validated Female Function Index.
Measured: Baseline then change over time at week 4,8,12
Secondary outcomes (1)
36 point RAND health survey.
Measured: Baseline then change over time at week 4,8,12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startApr 2016
- Primary completion18 Mar 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProHealth Care, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarit Aschkenazi, MD, Study director, ProHealth Care, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859285
- Sponsor's protocol ID
- IRB # 15-18
- Status last verified
- Mar 2020
- First submitted
- 20 Apr 2016
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function in Postmenopausal Women: A Double Blinded, Randomized Pilot Study Evaluating the Effects of Topical Clitoral Estradiol Cream
- ClinicalTrials.gov ID
- NCT02859285
- Acronym / sponsor ID
- IRB # 15-18
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Arousal, Orgasm, Clitoral, Estradiol, Post Menopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ProHealth Care, IncUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
The purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol vulvar cream | Active comparator | Other: Estradiol vulvar creamThe estradiol cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks. In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. |
| Placebo cream | Placebo comparator | Other: Placebo vulvar creamThe placebo cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks. In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction
Key exclusion criteria (6 listed)
- Not sexually active with a partner or an arousal device
- Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
- Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
- Allergic to estradiol
- Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
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 |
|---|---|---|
| Placebo vulvar cream | Other | Placebo cream |
| Estradiol vulvar cream | Other | Estradiol vulvar cream |
Primary outcome
19 point validated Female Function Index.
Time frame: Baseline then change over time at week 4,8,12
1 secondary outcome
36 point RAND health survey.
Time frame: Baseline then change over time at week 4,8,12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
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. This study is not recruiting at the moment.
Sarit Aschkenazi, MD study director
ProHealth Care, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol vulvar cream in people with Hypoactive Sexual Desire Disorder, run by ProHealth Care, Inc 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 13 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
19 point validated Female Function Index. (time frame: Baseline then change over time at week 4,8,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2020.