Chronic EndometritisNCT02680275
Efficacy of Dead Sea Peloid Gel in Chronic Endometritis
A study testing Dead Sea Peloid Gel in people with Chronic Endometritis, run by Scientific Center for Family Health and Human Reproduction Problems, Russia at 1 site in Russia.
Trial summary
This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Dead Sea Peloid Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2011to Jun 2013
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with miscarriage associated with chronic endometritis
- Women without mental disorders able to swallow tablets
Who cannot join
- sexually transmitted diseases
- endometrium hyperplasia and/or polyps
- uterina fibroids
- endocrine disorders
- trombophilia
Trial locations and contacts
1 site in 1 country.
Russia1 site
Scientific Center for Family Health and Human Reproduction Problems
Irkutsk, 664003
About this study
Official title: Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.
Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.
Read the detailed description
Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.
- Conditions
- Chronic Endometritis
- Being tested
- Dead Sea Peloid Gel
- Keywords
- Chronic endometritis, Miscarriage, Infertility
- Medical subject headings
- Abortion, Spontaneous, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dead Sea Peloid GelDrug
Also called Placebo Gel
intravaginally
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline,Dead Sea Peloid Gel,placebo | Experimental | 1. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by Dead Sea Peloid Gel , 60 ml per day fo 12 days, intravaginally
2. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally Receives: Drug: Dead Sea Peloid Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of spontaneous pregnancy the first year after treatment
Measured: during first year
Secondary outcomes (1)
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.
Measured: during 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EndometritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Center for Family Health and Human Reproduction Problems, Russia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Irina N. Danusevich, Scientific Center for Family Health and Human Reproduction Problems, Russia
- Investigators
- Marina A Darenskaya, MD, Study chair, Scientific Center for Family Health and Human Reproduction Problems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680275
- Sponsor's protocol ID
- 16
- Status last verified
- Sep 2015
- First submitted
- 22 Dec 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The study can generate the publications related to the outcomes. The investigator initiating the protocol (Protocol leader/coPI) will be the first (primary) author of the publication. The publication wil also could involve the names of the site investigators who have contributed to the study. The authorship order of the site investigators will be based upon personal contribution to the study, approved by the SCFHHRP (sponsor). The primary affiliation of the study is SCFHHRP.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT02680275
- Acronym / sponsor ID
- 16
- Conditions
- Chronic Endometritis
- Keywords
- Chronic endometritis, Miscarriage, Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Scientific Center for Family Health and Human Reproduction Problems, RussiaOther government
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Feb 2016 (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 evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.
Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.
Detailed description
Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxycycline,Dead Sea Peloid Gel,placebo | Experimental | Drug: Dead Sea Peloid Gel1. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by Dead Sea Peloid Gel , 60 ml per day fo 12 days, intravaginally 2. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally |
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 miscarriage associated with chronic endometritis
- Women without mental disorders able to swallow tablets
Key exclusion criteria (5 listed)
- sexually transmitted diseases
- endometrium hyperplasia and/or polyps
- uterina fibroids
- endocrine disorders
- trombophilia
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 |
|---|---|---|
| Dead Sea Peloid GelAlso: Placebo Gelintravaginally | Drug | Doxycycline,Dead Sea Peloid Gel,placebo |
Primary outcome
The prevalence of spontaneous pregnancy the first year after treatment
Time frame: during first year
1 secondary outcome
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.
Time frame: during 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 11 Feb 2016.
- Individual participant dataSharing planned: No. The study can generate the publications related to the outcomes. The investigator initiating the protocol (Protocol leader/coPI) will be the first (primary) author of the publication. The publication wil also could involve the names of the site investigators who have contributed to the study. The authorship order of the site investigators will be based upon personal contribution to the study, approved by the SCFHHRP (sponsor). The primary affiliation of the study is SCFHHRP.
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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.
Marina A Darenskaya, MD study chair
Scientific Center for Family Health and Human Reproduction Problems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dead Sea Peloid Gel in people with Chronic Endometritis, run by Scientific Center for Family Health and Human Reproduction Problems, Russia at 1 site in Russia.
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 5 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 11 Feb 2016. 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 Russia. 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.
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?
The prevalence of spontaneous pregnancy the first year after treatment (time frame: during first year). 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 11 Feb 2016.