Treatment for Inflammation

Phase-Based Estimates
3
Effectiveness
3
Safety
KEMRI, Thika, Kenya
Inflammation+3 More
Eligibility
18 - 65
Female
Eligible conditions
Inflammation

Study Summary

This study is evaluating whether different types of birth control pills may have different effects on the cervix and vagina.

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Eligible Conditions

  • Inflammation
  • Mucositis
  • Mucosal Inflammation
  • Contraceptive; Complications, Intrauterine

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes, 1 secondary outcome, and 1 other outcome in patients with Inflammation. Measurement will happen over the course of 4 weeks and 3 months after product use.

Month 3
Mucosal susceptibility to pathogens
Number of participants with changes to mucosal function
Number of participants with changes to mucosal health
Number of participants with systemic inflammation

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

Etonogestrel Implant

This trial requires 96 total participants across 4 different treatment groups

This trial involves 4 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Etonogestrel Implant
Drug
The ETG implant is a single, radiopaque, rod shaped implant containing 68 mg of etonogestrel. It is FDA approved for pregnancy prevention for 3 years.
Levonorgestrel IUS
Drug
The LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years.
Copper IUD
Drug
The copper IUD contains approximately 176 mg of copper wire wrapped around a vertical stem. It is FDA approved for pregnancy prevention for 10 years.
DMPA Sub-cutaneous
Drug
DMPA contains 104 mg of medroxyprogesterone acetate in 0.65 mL of fluid, administered by subcutaneous injection in the abdominal fat, thigh or skin over the deltoid muscle. It is FDA approved for pregnancy prevention for 14 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks and 3 months after product use
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks and 3 months after product use for reporting.

Closest Location

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
In general good health without any significant systemic disease and with an intact uterus and cervix.
History of Pap smears and follow-up consistent with standard, local clinical practice or willing to undergo a Pap smear at Visit 1
Willing to give voluntary consent and sign an informed consent form
If currently on a contraceptive product, willing to go off products and use condoms for birth control for a specified time
Age 18 to 50 years, inclusive
If in a relationship, must be with a partner who is not known to be HIV positive and has no know risk of sexually transmitted infections (STIs)
Willing and able to comply with protocol requirements, including accepting randomization to study contraceptive products

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes inflammation?

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Inflammation affects all the body systems implicated in chronic conditions such as obesity. In many people, however, the cause of inflammation remains unexplained leading to frustration and increased healthcare use.

Unverified Answer

What are common treatments for inflammation?

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Different treatments were used to treat common diseases of inflammation such as asthma, rhinitis, and inflammatory bowel disease. These treatments are commonly used to manage many inflammatory diseases.

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Can inflammation be cured?

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Inflammation is not an intrinsic disease of the body and can be suppressed by the body without damaging it. The body has natural mechanisms to keep it from damaging itself. Through these control mechanisms, the body can be kept in a state of relative homeostasis. Inflammation can thus be suppressed without damaging the brain, without eliminating or even diminishing the body's defenses and without diminishing the body's ability to perform its usual tasks. These defenses include control of the immune system by the brain, production of cytokines by cells and modulation of the immune system by immunoglobulins.

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What are the signs of inflammation?

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Symptoms that may reflect the signs of inflammation are fever and low-grade pyrexia. Signs of low-grade pyrexia are erythema, erythematous (redness of the skin), papular (punch) erythema and perspiration.\n

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How many people get inflammation a year in the United States?

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Our estimate, made only on the basis of a sample survey, is that 11% of Americans will have inflammation in a year. The survey method did not reflect the full spectrum of skin disorders, so we cannot say how common conditions such as atopic dermatitis and pityriasis are.

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What is inflammation?

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Inflammation is a physiological process that occurs in all living beings. Inflammation can be caused either by external or internal factors like bacteria, viruses or invading organisms. Inflammation is the body's normal reaction to a foreign body, which include pathogens, foreign proteins, cellular components or foreign substances that have triggered immunological response. The aim of the inflammatory response is to destroy invading pathogen via non-specific mechanisms. Inflammation is often transient, with neutrophils destroying invading and dead cells together with the pathogens.

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What are the latest developments in treatment for therapeutic use?

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Findings from a recent study is an early example of a large-scale, peer-reviewed database assessment of treatments of oral or maxillofacial inflammatory diseases and highlights the need for evidence-based treatments. There is no single optimal treatment for oral or maxillofacial inflammatory diseases, but more effective therapies are on the way.

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Has treatment proven to be more effective than a placebo?

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There were no differences in improvements in all outcomes between the active treatment group and the placebo group, and no significant differences in complication rates.

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What are the common side effects of treatment?

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The severity of side effects decreased with age. Most were gastrointestinal, including nausea, vomiting and diarrhea, while other side effects were relatively common regardless of treatment.

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Does inflammation run in families?

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[Inflammation] is strongly connected with genetic predisposition and its occurrence and course is a topic of ongoing research. This research would be of great help to clinicians, who have limited knowledge on the genetics of a disease and its course.

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How does treatment work?

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Data from a recent study of this work may help the clinician to understand how drugs suppress inflammation, because the findings are in line with research into biological pathways of inflammation.

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Have there been any new discoveries for treating inflammation?

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There have been many exciting advances in research that support the concept that inflammation drives the development of most diseases, such as cardiovascular diseases, type 2 diabetes, chronic obstructive pulmonary disease (COPD), cancer and neurological diseases. Current methods to treat inflammatory diseases are based on the assumption that inflammatory cells trigger the development of the diseases. For example, to treat arthritis, clinicians use biological agents to attempt to reduce inflammation level and therefore reduce arthritis manifestations. It is important to understand that there is a need for new therapeutic approaches that do not rely on the idea that the inflammatory process actually causes the disease.

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