MenopausePhase 2NCT02841137
Efficacy Study of Progesterone Tablet in Post-menopausal Women
A Phase 2 study testing Progesterone in people with Menopause, run by IBSA Institut Biochimique SA at 1 site in Canada.
Trial summary
This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to 25 Apr 2018
- Phase
- Phase 2
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability for the entire study period
- Post-menopausal female defined as:
- at least 12 consecutive months of spontaneous amenorrhea and
- less than 10 years of spontaneous amenorrhea, and
- Follicle-stimulating hormone (FSH) levels > 40 milli International Units/ml
- Females with an intact uterus
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- Moderate to severe climacteric vasomotor symptoms
- Aged of at least 40 years but not older than 65 years
- Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2
- Non- or ex-smoker;
- Endometrium thickness ≤4 mm on ultrasonography at screening
- Negative mammogram (dated < 2 years)
- Negative Pap smear test (dated < 1 year)
- Normal clinical breast examination
- Normal pelvic examination
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination, as determined by the medical investigator
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject
Who cannot join
- Use of any estrogen, progestin, or estrogen/progestin drug products, androgens, selective estrogen receptor modulators (SERMs), phytoestrogen supplements or natural products (soy, black cohosh, dong quai) during the past 3 months before the screening visit
- Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit
- Contraindications to hormone therapy:
- Active liver dysfunction or disease or history of severe liver disease
- Known, suspected or past history of hepatic tumors (benign or malign)
- Active or past history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke, coronary heart disease, transient ischemic attack)
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- Active or past history of venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism) or active thrombophlebitis
- Known, suspected or past history of breast cancer
- Known, suspected or past history of estrogen-dependent or progestin-dependent malignant neoplasia (e.g. endometrial cancer)
- Endometrial hyperplasia
- Porphyria cutanea tarda
- Genital bleeding
- Untreated hypertension
- Classical migraine
- Partial or complete loss of vision or diplopia due to ophthalmic vascular disease
- Presence of clinically significant screening ECG abnormalities as defined by medical judgment
- Presence of polyps
- Presence of uterine fibroids or other abnormalities affecting endometrial thickness measurement or precluding estrogen therapy
- Known hypersensitivity to the active substances or to any of the excipients contained in the drug products in particular to soya or peanut, as well as hereditary problems of fructose intolerance or phenylketonuria
- Participation in a concurrent clinical trial or another trial within the past 2 months
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
- Maintenance therapy with any drug or significant history of drug dependency, drug abuse or alcohol abuse within the last 2 years
- Presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study
- Serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient's reliability
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests
- Females who are pregnant according to a positive serum pregnancy test
- Presumption of subject's poor reliability/cooperation
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Progesterone 5, 10, and 20 mg Tablets Compared To Progesterone 100 mg Capsules on the Endometrial Thickness of Post-Menopausal Women Under Hormone Therapy - A Prospective, Open-Label, Randomized, Four-Arm, Parallel-Group, Phase II Clinical Trial
This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol.
- Conditions
- Menopause
- Being tested
- Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
comparison of different dosages of drug towards the active comparator
| Study group | Role | What they receive |
|---|---|---|
| progesterone 5 mg | Experimental | progesterone 5 mg tablet Receives: Drug: Progesterone |
| progesterone 10 mg | Experimental | progesterone 10 mg tablet Receives: Drug: Progesterone |
| progesterone 20 mg | Experimental | progesterone 20 mg tablet Receives: Drug: Progesterone |
| progesterone 100 mg | Active comparator | progesterone 100 mg capsule Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness change towards baseline (mm)
Measured: 3 months
Secondary outcomes (4)
histological assessment of the endometrium (presence of hyperplasia or proliferation)
Measured: 3 months
bleeding (presence or absence)
Measured: everyday over 3 months
quality of life (MENQOL Questionnaire)
Measured: 3 months
sleep scale from the Medical Outcomes Study (MOS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion2 Aug 2017
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deschamps, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841137
- Sponsor's protocol ID
- 16CDN-Prg02
- Status last verified
- Aug 2017
- First submitted
- 14 Jul 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progesterone 5, 10, and 20 mg Tablets Compared To Progesterone 100 mg Capsules on the Endometrial Thickness of Post-Menopausal Women Under Hormone Therapy - A Prospective, Open-Label, Randomized, Four-Arm, Parallel-Group, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02841137
- Acronym / sponsor ID
- 16CDN-Prg02
- Conditions
- Menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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.
This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| progesterone 5 mg | Experimental | Drug: Progesteroneprogesterone 5 mg tablet |
| progesterone 10 mg | Experimental | Drug: Progesteroneprogesterone 10 mg tablet |
| progesterone 20 mg | Experimental | Drug: Progesteroneprogesterone 20 mg tablet |
| progesterone 100 mg | Active comparator | Drug: Progesteroneprogesterone 100 mg capsule |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Availability for the entire study period
- Post-menopausal female defined as:
- Females with an intact uterus
- Moderate to severe climacteric vasomotor symptoms
- Aged of at least 40 years but not older than 65 years
Key exclusion criteria (31 listed)
- Use of any estrogen, progestin, or estrogen/progestin drug products, androgens, selective estrogen receptor modulators (SERMs), phytoestrogen supplements or natural products (soy, black cohosh, dong quai) during the past 3 months before the screening visit
- Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit
- Contraindications to hormone therapy:
- Presence of clinically significant screening ECG abnormalities as defined by medical judgment
- Presence of polyps
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 |
|---|---|---|
| Progesteronecomparison of different dosages of drug towards the active comparator | Drug | progesterone 10 mg, progesterone 100 mg, progesterone 20 mg, progesterone 5 mg |
Primary outcome
endometrial thickness change towards baseline (mm)
Time frame: 3 months
4 secondary outcomes
histological assessment of the endometrium (presence of hyperplasia or proliferation)
Time frame: 3 months
bleeding (presence or absence)
Time frame: everyday over 3 months
quality of life (MENQOL Questionnaire)
Time frame: 3 months
sleep scale from the Medical Outcomes Study (MOS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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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.
Deschamps principal investigator
Algorithme Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone in people with Menopause, run by IBSA Institut Biochimique SA at 1 site in Canada.
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 17 inclusion and 31 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: finished, as of the sponsor's last update on 11 Jun 2018. 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 Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
endometrial thickness change towards baseline (mm) (time frame: 3 months). 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 11 Jun 2018.