A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02710214
• Date of registration: 11/03/2016
• Prospective Registration: No
• Primary sponsor: University of California, San Francisco
• Public title: A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis MS-TSEC
• Scientific title: Effect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial.
• Date of first enrolment: February 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02710214
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Riley M Bove, MD
• Affiliation: Assistant Professor of Clinical Neurology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women aged 40-62 years.

- Perimenopausal: 6 months of amenorrhea; women who had a bi-lateral oophorectomy; women
without a uterus and who still have one or both ovaries, with FSH level > 20 mIU/mL
and estradiol = 50 pg/mL; women with a uterus who have skipped 2 or more menstrual
cycles with an amenorrhea interval; women who are using the Mirena IUD or who have had
an endometrial ablation and who still have one or both ovaries, with FSH level > 20
mIU/mL and estradiol = 50 pg/mL

- Bothersome MS symptoms: Mean of two or more hot flashes/night sweats per 24 hrs; Hot
flashes/night sweats rated as bothersome ('moderately' to 'a lot') and/or severe
('moderate' to 'severe') on 4 or more 12 hour (day/night) blocks of times

- In general good health (determined by medical history, blood pressure, and heart rate)

- No history of endometrial, ovarian, or breast cancer; No abnormal mammogram in the
last 2 years; Absence of any current severe or unstable medical illness

MS considerations:

- If using psychotropic medications: no change in the past 3 months

- If on DMT, no change in past 6 months Normal vitamin D levels (20-50 ng/mL)

Exclusion Criteria:

- BMI >35 kg/m2 as higher BMI may affect PK/PD

- Use of hormone therapy or hormonal contraceptives 2 months prior to enrollment

- Use of any prescribed therapy that is taken specifically for hot flashes in the past 1
month.

- Use of any over-the-counter or herbal therapies that are taken specifically for hot
flashes in the past 2 weeks.

- Use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors during
the 2 months before enrollment.

- Known hypersensitivity or contraindications to estrogen.

- Drug or alcohol abuse in the past 1 year

- Depression: moderate or severe (HAD score > 8) Other psychiatric disease meeting
DSM-IV criteria

- Lifetime diagnosis of psychosis or bipolar disorder.

- Pregnancy, intending pregnancy, or breast feeding

History of any of the following, as determined by clinician review of the potential
participant's medical history:

- Pre-breast cancer or high-risk breast cancer condition;

- Abnormal bleeding suggestive of endometrial pre-cancer;

- Endometrial hyperplasia;

- Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable or
under medical management;

- Active or past history of venous or arterial thromboembolism

- History of gallstones IF gallbladder intact

- Known or suspected estrogen-dependent neoplasia

- History of coronary artery disease

- Hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any
ingredients

- Known hepatic impairment or disease

- Thyroid dysfunction on thyroid medications

- Known hypoparathyroidism

- Blood test results indicating:

- Liver function tests: AST >2.5 times upper limit of normal; ALT >2.5 times upper limit
of normal; total bilirubin 1.5 times upper limit of normal;

- Kidney test: creatinine >1.5 mg/dL;

- Blood count: hematocrit <30%;

- Hemoglobin <8 g/dL.

- Current participation in another drug trial or intervention study.

- Inability or unwillingness to complete the study procedures.

MS considerations:

- Clinical relapse within the last three months (to ensure disease stability)

- Steroid treatment in prior 1 month

- Evidence of other structural brain disease (e.g. prior stroke)

MRI considerations:

- Metal implants

- Prior head trauma

- Claustrophobia requiring anxiolytic or sedation, or other contraindication to MRI.



Age minimum: 18 Years
Age maximum: 62 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Menopause

Multiple Sclerosis

Intervention(s)

Drug: Tissue Selective Estrogen Complex

Drug: Placebo

Primary Outcome(s)

Hot Flash Related Daily Interference Scale (HFRDIS) Score [Time Frame: Baseline and 8 weeks]

Change in the Expanded Disability Status Scale (EDSS) [Time Frame: Baseline and 8 weeks]

Change in Average Hot Flashes Per Day From Baseline to 8 Weeks [Time Frame: Baseline and 8 weeks]

Number of Participants Reporting Side Effects on the Treatment Satisfaction Questionnaire for Medication (TSQM) [Time Frame: 8 weeks]

Change in Number of Participants Who Experienced a Reduction in Hot Flashes Per 24 Hours From Baseline to 8 Weeks [Time Frame: Baseline and 8 weeks]

Secondary Outcome(s)

Change in the MS Quality of Life 54 (MSQOL-54) [Time Frame: Baseline and 8 weeks]

Change in the Bladder Control Scale (BLCS) [Time Frame: Baseline and 8 weeks]

Change in SDMT Z-score [Time Frame: Baseline and 8 weeks]

Change in the Multiple Sclerosis Rating Scale (MSRS) [Time Frame: Baseline and 8 weeks]

Change in the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) [Time Frame: Baseline and 8 weeks]

Number of Missed Doses [Time Frame: 8 weeks]

Change in the Symbol Digit Modalities Test (SDMT) Raw Score [Time Frame: Baseline and 8 weeks]

Number of Participants With New or Enhancing Lesions on MRI [Time Frame: 8 weeks]

Change in Letter Number Sequencing (LNS) Performance [Time Frame: Baseline and 8 weeks]

Secondary ID(s)

P0512236

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Multiple Sclerosis Society

Results

• Results available: Yes
• Date Posted: 29/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02710214