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Trial record 16 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

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ClinicalTrials.gov Identifier: NCT02680275
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Irina N. Danusevich, Scientific Center for Family Health and Human Reproduction Problems, Russia

Brief 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.

Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.


Condition or disease Intervention/treatment Phase
Chronic Endometritis Drug: Dead Sea Peloid Gel Not Applicable

Detailed Description:
Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
Study Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Doxycycline

Arm Intervention/treatment
Experimental: Doxycycline,Dead Sea Peloid Gel,placebo
  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
Drug: Dead Sea Peloid Gel
intravaginally
Other Name: Placebo Gel




Primary Outcome Measures :
  1. The prevalence of spontaneous pregnancy the first year after treatment [ Time Frame: during first year ]

Secondary Outcome Measures :
  1. The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment. [ Time Frame: during 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with miscarriage associated with chronic endometritis
  • Women without mental disorders able to swallow tablets

Exclusion Criteria: Clinical diagnosis of:

  • sexually transmitted diseases
  • endometrium hyperplasia and/or polyps
  • uterina fibroids
  • endocrine disorders
  • trombophilia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680275


Locations
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Russian Federation
Scientific Center for Family Health and Human Reproduction Problems
Irkutsk, Russian Federation, 664003
Sponsors and Collaborators
Scientific Center for Family Health and Human Reproduction Problems, Russia
Investigators
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Study Chair: Marina A Darenskaya, MD Scientific Center for Family Health and Human Reproduction Problems

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Responsible Party: Irina N. Danusevich, Principal Investigator, Scientific Center for Family Health and Human Reproduction Problems, Russia
ClinicalTrials.gov Identifier: NCT02680275     History of Changes
Other Study ID Numbers: 16
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.
Keywords provided by Irina N. Danusevich, Scientific Center for Family Health and Human Reproduction Problems, Russia:
Chronic endometritis
Miscarriage
Infertility
Additional relevant MeSH terms:
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Endometritis
Anti-Bacterial Agents
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Doxycycline
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents