Sexual Dysfunction, Physiological
Conditions
Keywords
Female sexual disorder, Aging, Menopause, Obstetrics/Gynecology, Female urogenital disorder
Brief summary
Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The improvements in sexual health and VVA symptom severity will be compared in each group. This study will help determine if ospemifene is a better treatment medication than conjugated estrogens.
Detailed description
Female sexual dysfunction (FSD) affects 57% of postmenopausal women. Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Women with FSD are 3.84 times as likely to also have VVA. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. This oral medication, taken daily, improves vaginal health, and has demonstrated protective activity in the breast and bone tissues. It also has not demonstrated any carcinogenic activity in the endometrium or liver. This study hopes to determine if ospemifene is superior to conjugated estrogens in improving sexual function and vaginal atrophy symptoms. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. Each participant will be informed of her assigned medication, and will receive a medication coupon to help offset the cost of the medication. Each medication is FDA-approved for long-term use of at least 52 weeks. For this study, a 12-week prescription for the medication will be sent electronically to the pharmacy of the participant's choice. The improvements in sexual health and VVA symptom severity will be compared in each group.
Interventions
DRUGOspemifene
Ospemifene is a selective estrogen receptor modulator (SERM), and it is the only SERM approved in the United States to treat moderate to severe dyspareunia associated with VVA. It is an oral medication that is taken as a 60mg tablet once daily. Food intake increases its absorption by 2 to 3-fold, and this is not impacted by the fat or calorie content of the food. It is metabolized primarily in the liver, and is excreted in feces.
DRUGVaginal conjugated estrogens
Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Vaginal estrogen is considered the medication of choice for treating vulvovaginal atrophy (VVA).
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Interested in resuming or continuing sexual activity * Greater than 12 months since last menstrual cycle or prior bilateral oophorectomy * Dyspareunia as a vulvovaginal atrophy symptom * Normal mammogram within 12 months prior to entry into the study
Exclusion criteria
* History or suspicion of breast carcinoma * History of hormone-dependent tumor * Genital bleeding of unknown cause * Ongoing vaginal infection * History of cerebrovascular accident (CVA), myocardial infarction (MI) or heart disease * Uncontrolled hypertension (HTN) over 160/100 * Serious disease or chronic condition that may prevent completion of study * Body Mass Index (BMI) over 40 * Hypercoagulable state, or currently on anticoagulant therapy * Use of any exogenous sex hormone within three months from study entry, or during the study * Pelvic surgery within the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index Score | Baseline, Week 12 | The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD). |
| Pain With Sex | Baseline, Week 12 | Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe. |
| Vaginal Dryness | Baseline, Week 12 | Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe. |
| Vaginal Itching | Baseline, Week 12 | Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe. |
| Vaginal Irritation | Baseline, Week 12 | Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between June 2017 and September 2017
Pre-assignment details
One individual gave informed consent to participate in the study and was randomized to the Estrogen arm.
Participants by arm
| Arm | Count |
|---|---|
| Ospemifene Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks | 0 |
| Estrogen Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Estrogen | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 0 | 51 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Female Sexual Function Index Score
The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).
Time frame: Baseline, Week 12
Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estrogen | Female Sexual Function Index Score | Baseline | 9 units on a scale |
Primary
Pain With Sex
Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Time frame: Baseline, Week 12
Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estrogen | Pain With Sex | Baseline | 2 units on a scale |
Primary
Vaginal Dryness
Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Time frame: Baseline, Week 12
Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estrogen | Vaginal Dryness | Baseline | 3 units on a scale |
Primary
Vaginal Irritation
Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Time frame: Baseline, Week 12
Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estrogen | Vaginal Irritation | Baseline | 3 units on a scale |
Primary
Vaginal Itching
Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Time frame: Baseline, Week 12
Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Estrogen | Vaginal Itching | Baseline | 3 units on a scale |