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Trial record 2 of 3 for:    NT-814

A Study of NT-814 in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (SWITCH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596762
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Nerre Therapeutics Ltd.

Brief Summary:
The purpose of this study is to determine the effectiveness of NT-814, taken once a day, in the treatment of troublesome post-menopausal symptoms.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Night Waking Drug: NT-814 Drug: Placebo Phase 2

Detailed Description:

This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group.

Four doses of NT-814 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups.

Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study.

Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : November 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: NT-814 160mg
160mg NT-814 capsules once daily
Drug: NT-814
NT-814 capsules

Experimental: NT-814 120mg
120mg NT-814 capsules once daily
Drug: NT-814
NT-814 capsules

Experimental: NT-814 80mg
80mg NT-814 capsules once daily
Drug: NT-814
NT-814 capsules

Experimental: NT-814 40mg
40mg NT-814 capsules once daily
Drug: NT-814
NT-814 capsules

Placebo Comparator: Placebo
Placebo capsules to match, once daily
Drug: Placebo
Placebo capsules




Primary Outcome Measures :
  1. Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 4 ]
  2. Mean change from baseline in frequency of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 12 ]
  3. Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 4 ]
  4. Mean change from baseline in severity of moderate and severe hot flashes recorded in patient diary [ Time Frame: Week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Postmenopausal
  • Body mass index between 18 and 38 kg/m2, inclusive
  • Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

  • Inability to comply with the use of prohibited and allowed medications as described in the protocol.
  • Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
  • Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
  • Any clinically significant abnormal laboratory test result(s) measured at Screening.
  • Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
  • Uncontrolled hypertension.
  • A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596762


Locations
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Sponsors and Collaborators
Nerre Therapeutics Ltd.
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Responsible Party: Nerre Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT03596762    
Other Study ID Numbers: 814-PM-02
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hot Flashes