MenopausePhase 1NCT01486979
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
A Phase 1 study testing estradiol, 10 mcg and estradiol, 25 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women only
- Conditions the study is for
- Menopause, Postmenopausal Vaginal Atrophy
- What is being tested?
- estradiol, 10 mcg and estradiol, 25 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to May 2007
- 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 60 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to use German language in speaking and writing
- Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
- Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
- Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
- Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
- Availability of a normal mammogram within one year prior to trial start
- Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations
Who cannot join
- Known or suspected allergy to trial product or related products
- Known, suspected or past history of breast cancer
- Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
- Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
- Abnormal genital bleeding of unknown etiology
- Previous estrogen and/ or progestin hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Being tested
- estradiol, 10 mcg, estradiol, 25 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 10 mcgDrug
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
estradiol, 25 mcgDrug
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: estradiol, 10 mcg |
| High dose | Active comparator | Not described Receives: Drug: estradiol, 25 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
Secondary outcomes (5)
Average plasma concentration (C average)
Maximal concentration (Cmax)
Minimal concentration (Cmin)
Time of maximal concentration (tmax)
Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2007
- Primary completionMay 2007
- Study completionMay 2007
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 MenopauseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486979
- Sponsor's protocol ID
- VAG-1850
- Other IDs
- 2006-005957-31
- Status last verified
- Feb 2017
- First submitted
- 5 Dec 2011
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Eugster-Hausmann M, Waitzinger J, Lehnick D. Minimized estradiol absorption with ultra-low-dose 10 microg 17beta-estradiol vaginal tablets. Climacteric. 2010 Jun;13(3):219-27. doi: 10.3109/13697137.2010.483297.
PubMed 20423242
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT01486979
- Acronym / sponsor ID
- VAG-1850
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 Dec 2011 (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 trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: estradiol, 10 mcg |
| High dose | Active comparator | Drug: estradiol, 25 mcg |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are able to use German language in speaking and writing
- Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
- Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
- Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
- Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
Key exclusion criteria (6 listed)
- Known or suspected allergy to trial product or related products
- Known, suspected or past history of breast cancer
- Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
- Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
- Abnormal genital bleeding of unknown etiology
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 |
|---|---|---|
| estradiol, 10 mcgOne vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks | Drug | Low dose |
| estradiol, 25 mcgOne vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks | Drug | High dose |
Primary outcome
Area under the curve (AUC)
5 secondary outcomes
Average plasma concentration (C average)
Maximal concentration (Cmax)
Minimal concentration (Cmin)
Time of maximal concentration (tmax)
Incidence of adverse events
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 8 Feb 2017.
- Results publication: PubMed 20423242Eugster-Hausmann M, Waitzinger J, Lehnick D. Minimized estradiol absorption with ultra-low-dose 10 microg 17beta-estradiol vaginal tablets. Climacteric. 2010 Jun;13(3):219-27. doi: 10.3109/13697137.2010.483297.
- Clinical Trials at Novo NordiskLink 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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 estradiol, 10 mcg and estradiol, 25 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 1 site in Germany.
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 7 inclusion and 6 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 8 Feb 2017. 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 Germany. 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?
Area under the curve (AUC). 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 NCT01486979, 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 8 Feb 2017.