Menopause Related ConditionsPhase 3PROGESTNCT03202186
Study of Progesterone in Treatment of Vasomotor Symptoms
A Phase 3 study testing Progesterone oral capsule in people with Menopause Related Conditions, run by BHR Pharma, LLC at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Progesterone oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 6 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Menopause Related Conditions
- Being tested
- Progesterone oral capsule, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone oral capsuleDrug
Oral capsule treatment
Placebo oral capsuleDrug
Oral capsule treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | oral administration of Placebo capsule Receives: Drug: Placebo oral capsule |
| Progesterone 200 mg | Experimental | oral administration of progesterone 200 mg Receives: Drug: Progesterone oral capsule |
| Progesterone 300 mg | Experimental | oral administration of progesterone 300 mg Receives: Drug: Progesterone oral capsule |
| Progesterone 400 mg | Experimental | oral administration of progesterone 400 mg Receives: Drug: Progesterone oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of moderate to severe vasomotor symptoms at 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
Measured: 12 weeks
Secondary outcomes (3)
Frequency of moderate to severe vasomotor symptoms at 4 weeks
the change vs. baseline of the frequency of moderate or severe VMS episodes (per day)
Measured: 4 weeks
Severity of vasomotor symptoms at 12 weeks
the change vs. baseline of the secerity of moderate or severe VMS episodes (per day)
Measured: 12 weeks
Severity of vasomotor symptoms at 4 weeks
the change vs. baseline of the severity of moderate or severe VMS episodes (per day)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Aug 2017
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Why it stopped: Inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled parallel arm study for 12 weeks
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- BHR Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Development, PhD, Study director, BESINS Healthcare Ireland Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202186
- Sponsor's protocol ID
- BHR-401-301
- Acronym
- PROGEST
- Status last verified
- Mar 2019
- First submitted
- 21 Jun 2017
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Trial Investigating the Efficacy of Different Doses of Progesterone Compared With Placebo for Treatment of Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT03202186
- Acronym / sponsor ID
- PROGEST / BHR-401-301
- Conditions
- Menopause Related Conditions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit subjects
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BHR Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Placebo controlled parallel arm study for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsuleoral administration of Placebo capsule |
| Progesterone 200 mg | Experimental | Drug: Progesterone oral capsuleoral administration of progesterone 200 mg |
| Progesterone 300 mg | Experimental | Drug: Progesterone oral capsuleoral administration of progesterone 300 mg |
| Progesterone 400 mg | Experimental | Drug: Progesterone oral capsuleoral administration of progesterone 400 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent
- Adult (≥ 18 years), postmenopausal women, where postmenopause is defined as
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone oral capsuleOral capsule treatment | Drug | Progesterone 200 mg, Progesterone 300 mg, Progesterone 400 mg |
| Placebo oral capsuleOral capsule treatment | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Frequency of moderate to severe vasomotor symptoms at 4 weeks
Time frame: 4 weeks
Severity of vasomotor symptoms at 12 weeks
Time frame: 12 weeks
Severity of vasomotor symptoms at 4 weeks
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Clinical Development, PhD study director
BESINS Healthcare Ireland Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone oral capsule in people with Menopause Related Conditions, run by BHR Pharma, LLC at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of moderate to severe vasomotor symptoms at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.