MenopausePhase 1NCT01085877
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
A Phase 1 study testing 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 compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Menopause, Postmenopausal Vaginal Atrophy
- What is being tested?
- estradiol, 25 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to May 2010
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able to use the German language, spoken and written
- Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
- Availability of a normal mammogram within 1 year prior to trial start
- Good general health
- No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician
Who cannot join
- Known or suspected allergy to estradiol or related products
- Known, suspected or past history of breast cancer
- Abnormal genital bleeding
- Previous oestrogen and/or progestin hormone replacement therapy
- Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
- Hot flushes which require systemic hormone replacement treatment
Show all 19Show fewer
- Known insulin dependent or non-insulin dependent diabetes mellitus
- Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
- Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
- Active arterial thrombosis or a documented history of this condition
- Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
- Known HIV infection based on laboratory result
- Porphyria
- Body Mass Index (BMI) above 30.0 kg/m2
- Cervical smear presenting PAP of more than class II
- Known or suspected vaginal infection requiring further treatment
- Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
- Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
- Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With Vaginal Atrophy
This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Being tested
- estradiol, 25 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 25 mcgDrug
Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)
estradiol, 25 mcgDrug
Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Active comparator | Not described Receives: Drug: estradiol, 25 mcg |
| Trial part 2 | Experimental | 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(0-t)), maximal concentration (Cmax) of estradiol after baseline correction
Measured: from dosing to day 4
Secondary outcomes (1)
Number of adverse events and local tolerability
Measured: from dosing to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT01085877
- Sponsor's protocol ID
- VAG-3821
- Other IDs
- U1111-1113-4908, 2009-017034-50, 2009
- Status last verified
- Jun 2014
- First submitted
- 11 Mar 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With Vaginal Atrophy
- ClinicalTrials.gov ID
- NCT01085877
- Acronym / sponsor ID
- VAG-3821
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Mar 2010 (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 compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial part 1 | Active comparator | Drug: estradiol, 25 mcg |
| Trial part 2 | Experimental | Drug: estradiol, 25 mcg |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are able to use the German language, spoken and written
- Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
- Availability of a normal mammogram within 1 year prior to trial start
- Good general health
- No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician
Key exclusion criteria (19 listed)
- Known or suspected allergy to estradiol or related products
- Known, suspected or past history of breast cancer
- Abnormal genital bleeding
- Previous oestrogen and/or progestin hormone replacement therapy
- Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
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, 25 mcgSingle dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B) | Drug | Trial part 1 |
| estradiol, 25 mcgSingle dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A) | Drug | Trial part 2 |
Primary outcome
Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction
Time frame: from dosing to day 4
1 secondary outcome
Number of adverse events and local tolerability
Time frame: from dosing to day 4
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 26 Jun 2014.
- 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, 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 5 inclusion and 19 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 26 Jun 2014. 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(0-t)), maximal concentration (Cmax) of estradiol after baseline correction (time frame: from dosing to day 4). 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 26 Jun 2014.