- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202186
Study of Progesterone in Treatment of Vasomotor Symptoms (PROGEST)
March 5, 2019 updated by: BHR Pharma, LLC
Double-Blind Trial Investigating the Efficacy of Different Doses of Progesterone Compared With Placebo for Treatment of Vasomotor Symptoms
The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women.
Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be tested against placebo in hierarchical order, starting with the highest dose.
Superiority will be defined as a significant (significance level α = 0.05) reduction of moderate to severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint of the study).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bernburg, Germany
- Fachärztin für Gynäkologie und Geburtshilfe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Willing and able to provide written informed consent
Adult (≥ 18 years), postmenopausal women, where postmenopause is defined as
- at least 12 months of spontaneous amenorrhea, or
- 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) levels > 40 mIU/ml, or
- status at least 6 weeks after bilateral oophorectomy with or without hysterectomy
- Non-smoker
- Mammography without pathological findings obtained within routine medical care no longer than 12 months prior to screening visit
- Cervical smear (Papanicolaou test) without pathological findings (i.e. < III) obtained no longer than 12 months prior to screening visit
In addition subjects need to fulfil the following criterion in order to be randomized (i.e. to enter the treatment period):
- A minimum of 50 moderate to severe VMS episodes over the last 7 consecutive days prior to the baseline visit, as documented in the patient diary.
Exclusion Criteria:
- Use of any hormone replacement therapy (including phytoestrogens and other plant-derived sex hormones) during the previous 12 weeks prior to screening
- Ongoing or suspicion of any estrogen-dependent malignancy.
- Endometrial thickness ≥ 5 mm at screening visit
- Any history or current presence or suspicion of breast cancer, including carcinoma in situ and other pre-cancerous conditions
- Active malignant disease of any organ system (except for basal localized basal cell carcinoma of the skin) or history thereof in the last 5 years prior to screening visit
- Vaginal bleeding due to unidentified reason within 6 weeks prior to screening
- Ongoing venous thromboembolic event or history thereof within 12 months prior to screening visit
- Known severe renal insufficiency (defined as glomerular filtration rate, GFR < 30 mg/min/1.73 m²) at screening visit
- Known lipid metabolism disturbances of genetic origin (e.g. familial hypercholesterolemia, familial hypertriglyceridemia)
- Acute or chronic liver diseases or a history of liver disease with liver enzymes having not normalized since then
- Severe disturbances of hepatic function (including porphyria), hepatic tumors, also in medical history
- Rotor syndrome or Dubin-Johnson syndrome
- History of icterus or generalized pruritus during a previous pregnancy
- History of myocardial infarction, stroke or transient ischemic attack or severe cardiac disease, including symptomatic chronic heart failure
- Ongoing major depression
- Subjects who currently take or are planned to commence treatment with SSRI, SNRI for any reason during the course of the study
- Diabetes mellitus
- Hypersensitivity to progesterone or excipients (e.g. soy) of the study medication
- Medical history of HIV infection
- Concomitant diseases or therapies that may cause VMS or affect VMS frequency or severity, e.g. but not limited to poorly controlled thyroid dysfunction (thyroid medication should be stable for at least 12 weeks prior to screening and TSH levels should be within range), fear disorders (e.g. panic disorders)
- Participation in a clinical trial or intake of any investigational medicinal product within three months prior to screening visit
- Previous participation in this clinical trial
- Known or suspected drug or alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
oral administration of Placebo capsule
|
Oral capsule treatment
|
EXPERIMENTAL: Progesterone 200 mg
oral administration of progesterone 200 mg
|
Oral capsule treatment
|
EXPERIMENTAL: Progesterone 300 mg
oral administration of progesterone 300 mg
|
Oral capsule treatment
|
EXPERIMENTAL: Progesterone 400 mg
oral administration of progesterone 400 mg
|
Oral capsule treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of moderate to severe vasomotor symptoms at 12 weeks
Time Frame: 12 weeks
|
the change vs. baseline of the frequency of moderate or severe VMS episodes (per day) after 12 weeks of treatment with BHR-401or placebo
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of moderate to severe vasomotor symptoms at 4 weeks
Time Frame: 4 weeks
|
the change vs. baseline of the frequency of moderate or severe VMS episodes (per day)
|
4 weeks
|
Severity of vasomotor symptoms at 12 weeks
Time Frame: 12 weeks
|
the change vs. baseline of the secerity of moderate or severe VMS episodes (per day)
|
12 weeks
|
Severity of vasomotor symptoms at 4 weeks
Time Frame: 4 weeks
|
the change vs. baseline of the severity of moderate or severe VMS episodes (per day)
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 12 weeks
|
12 weeks
|
|
Kupperman Index
Time Frame: 4 and 12 weeks
|
Change vs. baseline of postmenopausal symptoms as assessed by the physician by means of the Kupperman Index inventory after 4 weeks and 12 weeks of treatment
|
4 and 12 weeks
|
Sleep quality assessed by means of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 and 12 weeks
|
Change in subjective sleep quality vs. baseline as assessed by means of the Pittsburgh Sleep Quality Index (PSQI) after 4 weeks and 12 weeks of treatment
|
4 and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Head of Clinical Development, PhD, BESINS Healthcare Ireland Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ACTUAL)
December 6, 2018
Study Completion (ACTUAL)
December 6, 2018
Study Registration Dates
First Submitted
June 21, 2017
First Submitted That Met QC Criteria
June 26, 2017
First Posted (ACTUAL)
June 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2019
Last Update Submitted That Met QC Criteria
March 5, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHR-401-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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