Secondary AmenorrheaPhase 4NCT00160199
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
A Phase 4 study testing PROMETRIUM® 300 mg and PROMETRIUM® 400 mg in people with Secondary Amenorrhea, run by Solvay Pharmaceuticals at 42 sites in United States.
Trial summary
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Secondary Amenorrhea
- What is being tested?
- PROMETRIUM® 300 mg and PROMETRIUM® 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 42 sitesUnited States
- Study dates
- Nov 2004to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with secondary amenorrhea
- Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
Who cannot join
- Primary amenorrhea
- Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- Peanut allergy
- Allergy to progestational steroids
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Site 46
Atlanta, Georgia
Site 14
Aventura, Florida
Site 42
Avon, Connecticut
Site 7
Baltimore, Maryland
Site 6
Baton Rouge, Louisiana
Site 39
Carmichael, California
Site 36
Champaign, Illinois
Site 12
Chicago, Illinois
Site 33
Cincinnati, Ohio
Site 40
Clearwater, Florida
Site 8
Conroe, Texas
Site 11
Corpus Christi, Texas
Site 17
Encinitas, California
Site 32
Erie, Pennsylvania
Site 13
Greenville, South Carolina
Site 3
Groton, Connecticut
Site 47
Hershey, Pennsylvania
Site 27
Houston, Texas
Site 34
Houston, Texas
Site 5
Jonesboro, Arkansas
Site 29
Mobile, Alabama
Site 41
Montgomery, Alabama
Site 23
New Bern, North Carolina
Site 22
New Britian, Connecticut
Site 45
New York, New York
Site 19
Norfolk, Virginia
Site 44
Philadelphia, Pennsylvania
Site 38
Pottstown, Pennsylvania
Site 43
Powder Springs, Georgia
Site 16
Reno, Nevada
Site 35
Salt Lake City, Utah
Site 24
San Antonio, Texas
Site 10
San Diego, California
Site 4
Seattle, Washington
Site 2
St Louis, Missouri
Site 26
Tucson, Arizona
Site 9
Waterbury, Connecticut
Site 37
West Hartford, Connecticut
Site 1
West Palm Beach, Florida
Site 30
West Palm Beach, Florida
Site 15
Winston-Salem, North Carolina
Site 28
Winston-Salem, North Carolina
About this study
Official title: Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
- Conditions
- Secondary Amenorrhea
- Being tested
- PROMETRIUM® 300 mg, PROMETRIUM® 400 mg
- Keywords
- To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMETRIUM® 300 mgDrug
300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
PROMETRIUM® 400 mgDrug
400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PROMETRIUM® 300 mg |
| 2 | Active comparator | Not described Receives: Drug: PROMETRIUM® 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secretory Conversion of the Endometrium
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Measured: End of the study (Days 85)
Number of Subjects With Withdrawal Bleeding
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
Measured: After first and second cycle (cycle=28 days)
Secondary outcomes (5)
Maximum Intensity of Withdrawal Bleeding After Any Cycle
The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
Measured: Duration of withdrawal bleed
The Duration of Withdrawal Bleeding After the First Treatment Cycle
The numbers of days the subjects actually bled after the end of the first treatment cycle.
Measured: End of the first cycle of treatment (cycle=28 days)
The Duration of Withdrawal Bleeding After Second Treatment Cycle
The numbers of days the subjects actually bled after the end of the second treatment cycle
Measured: End of the second cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After First Treatment Cycle
The number of days between the first cycle of treatment and the withdrawal bleeding.
Measured: End of the first cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After Second Treatment Cycle
The number of days between the second cycle of treatment and the withdrawal bleeding
Measured: End of the second cycle of treatment (cycle=28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary AmenorrheaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT00160199
- Sponsor's protocol ID
- S168.4.002
- Status last verified
- Jun 2010
- First submitted
- 8 Sep 2005
- Last updated
- 7 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea
- ClinicalTrials.gov ID
- NCT00160199
- Acronym / sponsor ID
- S168.4.002
- Conditions
- Secondary Amenorrhea
- Keywords
- To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 2 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PROMETRIUM® 300 mg |
| 2 | Active comparator | Drug: PROMETRIUM® 400 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with secondary amenorrhea
- Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
Key exclusion criteria (4 listed)
- Primary amenorrhea
- Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- Peanut allergy
- Allergy to progestational steroids
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 |
|---|---|---|
| PROMETRIUM® 300 mg300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles | Drug | 1 |
| PROMETRIUM® 400 mg400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles | Drug | 2 |
Primary outcome
Secretory Conversion of the Endometrium
Time frame: End of the study (Days 85)
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Number of Subjects With Withdrawal Bleeding
Time frame: After first and second cycle (cycle=28 days)
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
5 secondary outcomes
Maximum Intensity of Withdrawal Bleeding After Any Cycle
Time frame: Duration of withdrawal bleed
The Duration of Withdrawal Bleeding After the First Treatment Cycle
Time frame: End of the first cycle of treatment (cycle=28 days)
The Duration of Withdrawal Bleeding After Second Treatment Cycle
Time frame: End of the second cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After First Treatment Cycle
Time frame: End of the first cycle of treatment (cycle=28 days)
Time to Withdrawal Bleeding After Second Treatment Cycle
Time frame: End of the second cycle of treatment (cycle=28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PROMETRIUM® 300 mg and PROMETRIUM® 400 mg in people with Secondary Amenorrhea, run by Solvay Pharmaceuticals at 42 sites in United States.
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 2 inclusion and 4 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Secretory Conversion of the Endometrium (time frame: End of the study (Days 85)). The study lists 2 primary outcomes in all. 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 7 Jul 2010.