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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
oral administration of Placebo capsule
Drug: Placebo oral capsule
Oral capsule treatment
EXPERIMENTAL: Progesterone 200 mg
oral administration of progesterone 200 mg
Drug: Progesterone oral capsule
Oral capsule treatment
EXPERIMENTAL: Progesterone 300 mg
oral administration of progesterone 300 mg
Drug: Progesterone oral capsule
Oral capsule treatment
EXPERIMENTAL: Progesterone 400 mg
oral administration of progesterone 400 mg
Drug: Progesterone oral capsule
Oral capsule treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BHR Pharma, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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