AmenorrheaPhase 2NCT00196391
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea
A Phase 2 study testing DR-2021a, DR-2021b and DR-2021c in people with Amenorrhea, run by Duramed Research at 27 sites in United States.
Trial summary
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Amenorrhea
- What is being tested?
- DR-2021a, DR-2021b and DR-2021c
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 27 sitesUnited States
- Study dates
- Sep 2005to Apr 2007
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Not pregnant
- Secondary amenorrhea or oligomenorrhea of at least 50 days duration
- Not currently on any hormonal medication
- Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)
Who cannot join
- Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
- Use of any hormonal birth control within the last 3 months
- Any contraindication to the use of progestins
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Duramed Investigational Site
Alliance, Nebraska, 69301
Duramed Investigational Site
Atlanta, Georgia, 30328
Duramed Investigational Site
Carmichael, California, 95608
Duramed Investigational Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Dallas, Texas, 75390
Duramed Investigational Ste
Dawsonville, Georgia, 30534
Duramed Investigational Site
Douglasville, Georgia, 30134
Duramed Investigational Site
Gainesville, Florida, 32605
Duramed Investigational Site
Houston, Texas, 77030
Duramed Investigational Site
Houston, Texas, 77074
Duramed Investigational Site
Laurel, Maryland, 20707
Duramed Investigational Site
Lawrenceville, New Jersey, 08648
Duramed Investigational Site
Leesburg, Florida, 34748
Duramed Investigational Site
Medford, Oregon, 97505
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Mobile, Alabama, 36608
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
Pueblo, Colorado, 81001
Duramed Investigational Site
San Diego, California, 92123
Duramed Investigational Site
San Diego, California, 92130
Duramed Investigational Site
St Louis, Missouri, 63110
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
Read the detailed description
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.
- Conditions
- Amenorrhea
- Being tested
- DR-2021a, DR-2021b, DR-2021c, DR-2021d, DR-2021e
- Keywords
- secondary amenorrhea, progesterone
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-2021aDrug
Also called Micronized progesterone
1 capsule daily for 10 days
DR-2021bDrug
Also called Micronized Progesterone
1 capsule daily for 10 days
DR-2021cDrug
Also called Micronized Progesterone
1 capsule daily for 10 days
DR-2021dDrug
Also called Micronized Progesterone
1 capsule daily for 10 days
DR-2021eDrug
1 capsule daily for 10 days
PlaceboOther
1 matching placebo capsule for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DR-2021a |
| 2 | Experimental | Not described Receives: Drug: DR-2021b |
| 3 | Experimental | Not described Receives: Drug: DR-2021c |
| 4 | Experimental | Not described Receives: Drug: DR-2021d |
| 5 | Experimental | Not described Receives: Drug: DR-2021e |
| 6 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Measured: Throughout study period
Secondary outcomes (1)
Time to onset, duration, and severity of withdrawal bleeding.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duramed Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196391
- Sponsor's protocol ID
- DR-MPG-201
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea
- ClinicalTrials.gov ID
- NCT00196391
- Acronym / sponsor ID
- DR-MPG-201
- Conditions
- Amenorrhea
- Keywords
- secondary amenorrhea, progesterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 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.
This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.
Detailed description
In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DR-2021a |
| 2 | Experimental | Drug: DR-2021b |
| 3 | Experimental | Drug: DR-2021c |
| 4 | Experimental | Drug: DR-2021d |
| 5 | Experimental | Drug: DR-2021e |
| 6 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Not pregnant
- Secondary amenorrhea or oligomenorrhea of at least 50 days duration
- Not currently on any hormonal medication
- Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)
Key exclusion criteria (3 listed)
- Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
- Use of any hormonal birth control within the last 3 months
- Any contraindication to the use of progestins
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 |
|---|---|---|
| DR-2021aAlso: Micronized progesterone1 capsule daily for 10 days | Drug | 1 |
| DR-2021bAlso: Micronized Progesterone1 capsule daily for 10 days | Drug | 2 |
| DR-2021cAlso: Micronized Progesterone1 capsule daily for 10 days | Drug | 3 |
| DR-2021dAlso: Micronized Progesterone1 capsule daily for 10 days | Drug | 4 |
| DR-2021e1 capsule daily for 10 days | Drug | 5 |
| Placebo1 matching placebo capsule for 10 days | Other | 6 |
Primary outcome
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.
Time frame: Throughout study period
1 secondary outcome
Time to onset, duration, and severity of withdrawal bleeding.
Time frame: Throughout study
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 30 Jul 2014.
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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.
Duramed Protocol Chair study chair
Duramed Research, Inc.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DR-2021a, DR-2021b and DR-2021c in people with Amenorrhea, run by Duramed Research at 27 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 4 inclusion and 3 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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 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?
Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. (time frame: Throughout study period). 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 30 Jul 2014.