PharmacodynamicsPhase 1NCT00754871
Pharmacodynamic Characterization of Dienogest
A Phase 1 study testing Dienogest (81150037), Dienogest (81150231) and Dienogest (SH T00660A) in people with Pharmacodynamics, run by Bayer at 1 site in Netherlands.
Trial summary
This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamics
- What is being tested?
- Dienogest (81150037), Dienogest (81150231) and Dienogest (SH T00660A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 1
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Body-Mass-Index (BMI): 18 - 30 kg/m²
- Healthy female volunteers
- Age 18-35 years (smoker not older than 30 years, inclusive)
- At least 3 months since delivery, abortion or lactation
- Willingness to use non-hormonal methods of contraception during entire study
Who cannot join
- Contraindications for use of progesterone-only pills or combined oral contraceptives (e.g. history of venous/arterial thromboembolic disease)
- Use of systemic or topical medications or substances which oppose the study objectives or which might influence them within 4 weeks prior to start of the pre-treatment cycle
- Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Dose-controlled Study to Evaluate Pharmacodynamic Properties of Four Oral Doses of Dienogest (DNG) in 100 Healthy Young Female Volunteers Over a Period of Two Cycles up to a Maximum of 72 Days
This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.
- Conditions
- Pharmacodynamics
- Being tested
- Dienogest (81150037), Dienogest (81150231), Dienogest (SH T00660A), Dienogest (81150746)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest (81150037)Drug
daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
Dienogest (81150231)Drug
daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
Dienogest (SH T00660A)Drug
daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
Dienogest (81150746)Drug
daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Dienogest (81150037) |
| Arm 2 | Experimental | Not described Receives: Drug: Dienogest (81150231) |
| Arm 3 | Experimental | Not described Receives: Drug: Dienogest (SH T00660A) |
| Arm 4 | Experimental | Not described Receives: Drug: Dienogest (81150746) |
What is being measured
The primary outcome is the main question the study is designed to answer.
No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
Measured: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
Secondary outcomes (7)
Course of gonadotropins (FSH, LH, P, E2)
Measured: During pre-treatment and treatment cycles (3 months)
Endometrial thickness
Measured: During pre-treatment and treatment cycles (3 months)
Grading of ovarian activity
Measured: During pre-treatment and treatment cycles (3 months)
Effects on the cervix and the cervical mucus
Measured: During pre-treatment and treatment cycles (3 months)
mRNA expression profile of endometrial biopsies and in blood
Measured: once in pre-treatment and during treatment
Concentrations of DNG in serum
Measured: During pre-treatment and treatment cycles (3 months)
Safety and tolerability
Measured: During pre-treatment and treatment cycles (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacodynamicsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754871
- Sponsor's protocol ID
- 13180
- Other IDs
- 2008-003611-13, 2008
- Status last verified
- Jan 2015
- First submitted
- 17 Sep 2008
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270011423664. Epub 2011 Nov 29.
PubMed 22128200
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Dose-controlled Study to Evaluate Pharmacodynamic Properties of Four Oral Doses of Dienogest (DNG) in 100 Healthy Young Female Volunteers Over a Period of Two Cycles up to a Maximum of 72 Days
- ClinicalTrials.gov ID
- NCT00754871
- Acronym / sponsor ID
- 13180
- Conditions
- Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Sep 2008 (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 study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dienogest (81150037) |
| Arm 2 | Experimental | Drug: Dienogest (81150231) |
| Arm 3 | Experimental | Drug: Dienogest (SH T00660A) |
| Arm 4 | Experimental | Drug: Dienogest (81150746) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Body-Mass-Index (BMI): 18 - 30 kg/m²
- Healthy female volunteers
- Age 18-35 years (smoker not older than 30 years, inclusive)
- At least 3 months since delivery, abortion or lactation
Key exclusion criteria (3 listed)
- Contraindications for use of progesterone-only pills or combined oral contraceptives (e.g. history of venous/arterial thromboembolic disease)
- Use of systemic or topical medications or substances which oppose the study objectives or which might influence them within 4 weeks prior to start of the pre-treatment cycle
- Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
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 |
|---|---|---|
| Dienogest (81150037)daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days | Drug | Arm 1 |
| Dienogest (81150231)daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days | Drug | Arm 2 |
| Dienogest (SH T00660A)daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days | Drug | Arm 3 |
| Dienogest (81150746)daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days | Drug | Arm 4 |
Primary outcome
No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
Time frame: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
7 secondary outcomes
Course of gonadotropins (FSH, LH, P, E2)
Time frame: During pre-treatment and treatment cycles (3 months)
Endometrial thickness
Time frame: During pre-treatment and treatment cycles (3 months)
Grading of ovarian activity
Time frame: During pre-treatment and treatment cycles (3 months)
Effects on the cervix and the cervical mucus
Time frame: During pre-treatment and treatment cycles (3 months)
mRNA expression profile of endometrial biopsies and in blood
Time frame: once in pre-treatment and during treatment
Concentrations of DNG in serum
Time frame: During pre-treatment and treatment cycles (3 months)
Safety and tolerability
Time frame: During pre-treatment and treatment cycles (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 27 Jan 2015.
- Results publication: PubMed 22128200Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270011423664. Epub 2011 Nov 29.
- Click here and search for product information by EMALink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dienogest (81150037), Dienogest (81150231) and Dienogest (SH T00660A) in people with Pharmacodynamics, run by Bayer at 1 site in Netherlands.
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 6 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 27 Jan 2015. 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned (time frame: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754871, which also lists 1 linked publication.
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 27 Jan 2015.