PostmenopausePhase 3NCT00251082
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
A Phase 3 study testing continuous combined estradiol and dydrogesterone in people with Postmenopause, run by Solvay Pharmaceuticals at 18 sites in 5 countries.
Trial summary
To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- continuous combined estradiol and dydrogesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Dec 2005to Oct 2007
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-hysterectomised postmenopausal women
- Amenorrhoea for >= 12 months
- Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
Who cannot join
- Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
- Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
- Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.
- The presence of an endometrial polyp at baseline.
- Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
- Estradiol pellet/implant therapy during the past 6 months.
- Previous systemic unopposed estrogen replacement therapy over 6 months or more.
- History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
France4 sites
Site 23
Cannes
Site 24
Cannes
Site 21
Montpellier
Site 22
Montpellier
Romania4 sites
Site 41
Bucharest
Site 42
Bucharest
Site 44
Bucharest
Site 43
Craiova, Jud.Dolj
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone
To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year
- Conditions
- Postmenopause
- Being tested
- continuous combined estradiol and dydrogesterone, Placebo
- Keywords
- hormone replacement, vasomotoric symptoms, bleeding pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous combined estradiol and dydrogesteroneDrug
0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
continuous combined estradiol and dydrogesteroneDrug
1 Mg Estradiol and 5 Mg Dydrogesterone
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: continuous combined estradiol and dydrogesterone |
| B | Active comparator | Not described Receives: Drug: continuous combined estradiol and dydrogesterone |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the number of moderate to severe hot flushes from baseline to week 13
Measured: 12 weeks
Secondary outcomes (5)
Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;
Measured: 12 weeks
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
Measured: 52 weeks
Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
Measured: 52 weeks
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
Measured: 52 weeks
QualiPause Inventory 7D: weighted sum score of the symptoms
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251082
- Sponsor's protocol ID
- S102.3.119
- Other IDs
- 2004-00215-25, 2004
- Status last verified
- Mar 2008
- First submitted
- 8 Nov 2005
- Last updated
- 12 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone
- ClinicalTrials.gov ID
- NCT00251082
- Acronym / sponsor ID
- S102.3.119
- Conditions
- Postmenopause
- Keywords
- hormone replacement, vasomotoric symptoms, bleeding pattern
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Nov 2005 (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.
To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: continuous combined estradiol and dydrogesterone |
| B | Active comparator | Drug: continuous combined estradiol and dydrogesterone |
| C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-hysterectomised postmenopausal women
- Amenorrhoea for >= 12 months
- Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range
Key exclusion criteria (8 listed)
- Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
- Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
- Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.
- The presence of an endometrial polyp at baseline.
- Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
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 |
|---|---|---|
| continuous combined estradiol and dydrogesterone0.5 Mg Estradiol and 2.5 Mg Dydrogesterone | Drug | A |
| continuous combined estradiol and dydrogesterone1 Mg Estradiol and 5 Mg Dydrogesterone | Drug | B |
| PlaceboPlacebo | Drug | C |
Primary outcome
The change in the number of moderate to severe hot flushes from baseline to week 13
Time frame: 12 weeks
5 secondary outcomes
Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;
Time frame: 12 weeks
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
Time frame: 52 weeks
Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
Time frame: 52 weeks
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
Time frame: 52 weeks
QualiPause Inventory 7D: weighted sum score of the symptoms
Time frame: 52 weeks
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 12 Mar 2008.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing continuous combined estradiol and dydrogesterone in people with Postmenopause, run by Solvay Pharmaceuticals at 18 sites in 5 countries.
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 3 inclusion and 8 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 12 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Poland, Romania, Croatia, Russia. 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 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?
The change in the number of moderate to severe hot flushes from baseline to week 13 (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 12 Mar 2008.