Depot-Medroxyprogestereone Acetate for Relapse

Phase-Based Estimates
3
Effectiveness
3
Safety
University of Arizona, Tucson, AZ
Relapse+3 More
Depot-Medroxyprogestereone Acetate - Drug
Eligibility
18 - 65
Female
Eligible conditions
Relapse

Study Summary

This study is evaluating whether a smoking cessation intervention can help women quit smoking and reduce the risk of relapse.

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Eligible Conditions

  • Relapse
  • Recurrence
  • Smoking, Cessation
  • Smoking Reduction
  • Smoking

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Depot-Medroxyprogestereone Acetate will improve 3 primary outcomes in patients with Relapse. Measurement will happen over the course of 12 weeks.

12 weeks
Infant State of Health Questionnaire (ISHQ)
Postpartum Smoking Relapse
Relapse-Related Risk Factors: Craving

Trial Safety

Safety Estimate

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

Trial Design

4 Treatment Groups

Progesterone + Placebo
Progesterone + DMPA
Placebo group

This trial requires 312 total participants across 4 different treatment groups

This trial involves 4 different treatments. Depot-Medroxyprogestereone Acetate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Progesterone + DMPAParticipants in this group will receive progesterone plus depot medroxyprogesterone acetate (DMPA)
Progesterone + PlaceboParticipants in this group will receive progesterone plus the placebo injection treatment
Placebo + DMPAParticipants in this group will receive the placebo oral pill treatment plus depot medroxyprogesterone acetate (DMPA)
Placebo + PlaceboParticipants in this group will receive the placebo oral pill and injection treatments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Depot-Medroxyprogestereone Acetate
2018
Completed Early Phase 1
~520

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Closest Location

University of Arizona - Tucson, AZ

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. You must have received 1 prior treatment for Relapse or one of the other 3 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
willingness to use non-hormonal contraceptives postpartum if sexually active until 12 weeks postpartum
stable physical and mental health with confirmed, uncomplicated pregnancy at gestational week 30-35
established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider
self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment
history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale

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 are common treatments for relapse?

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Complete response should be considered as the treatment of choice. There are no current treatments that appear to have significant impact on relapse. Relapse is usually manageable using well tolerated regimens.

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

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The numbers remain small, but the data are encouraging for our ongoing efforts. These numbers are consistent with reports from other countries. Our work thus contributes to international information regarding cancer progression and relapse.

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What is relapse?

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Relapse is the return of symptoms to a level that was close to the pre-treatment level. Rates of relapse are significantly higher for individuals that have a relapsed mood disorder.

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What are the signs of relapse?

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The sign of relapse is either a strong desire to return to the lifestyle changes made during remission or an increased need of medication due to the desire to return to the symptoms that led to relapse. In either case these symptoms may be masked with other depressive symptoms, which frequently accompany schizophrenia.

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Can relapse be cured?

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Relapses following standard treatment for relapse-prone cancers are fairly infrequent. They usually occur very late in the first year of observation after cessation of relapse treatment, in an otherwise well-controlled remission.

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What causes relapse?

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Relapse of IED after complete remission is more common after alcohol treatment relapse versus drug treatment relapse. When IED relapse after treatment with anti-ED medications, the number of anti-ED medication doses decreases but the total number of non-medication doses, including alcohol, increases. Drugs remain the primary cause of relapse for IED that do not respond to medication and do not comply.

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What is depot-medroxyprogestereone acetate?

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Depo-Medroxyprogesterone acetate provides significantly higher progesterone responses to hCG and E2 in post-oophorectomy amenorrheic patients than to a gonadotropin-releasing hormone agonist. Additionally, there are significantly greater changes in endometrial thickness and E2 levels (24 h) with DMPA. This new, longer-lasting depot formulation of Medroxyprogesterone acetate might be a better choice under hormonal replacement therapy in patients with preoperative amenorrhea, and could be a good alternative to transdermal progesterone therapy.

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What does depot-medroxyprogestereone acetate usually treat?

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DMPP seems to be effective in the primary treatment of hormonal-dependent menopausal symptoms. However, the fact that we usually use this medication with progestins other than MPA indicates that there are no absolute contraindications for the use of MPA. The number of patients with a uterus is probably so low that the presence of uterine fibroids will not be problematic.

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Does relapse run in families?

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We were unable to find a strong association of illness behavior between relatives. The number of siblings with IBD, or any type of IBD, was significantly higher in our family, and siblings may have more illness behavior than the general population. However, because sibling-selection for these illnesses can be biased, we will continue to add new families to our study so we can assess this family risk factor.

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Has depot-medroxyprogestereone acetate proven to be more effective than a placebo?

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Depot-metroderm DMPPA is a more effective formulation as compared to a placebo after 12 months. Patients on depot-medroxyprogesteen DMPPA have the possibility to decrease their dose of metenephrines by 33%, resulting in less side effects. Future long-term studies on these patients may show whether this is also an advantage with a lower risk of flare-up.

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What are the common side effects of depot-medroxyprogestereone acetate?

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These common side effects of depot medroxyprogestrelone acetate are not predictable as a result of the fact that both the formulation and the dose may have influence on the pattern of reaction. However, they often appear sooner or more frequently in women taking more than 40 mg than in those taking less than 40 mg. Some of these side effects (eg, nausea, breast tenderness) are, however, probably more often a part of the menstrual cycle. The most common side effects of depot medroxyprogestrelone acetate during cycles are, however, menstrual irregularities and breast tenderness. Some of the other side effects of depot medroxyprogestrelone acetate are listed at the end of the paper.

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Who should consider clinical trials for relapse?

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A recent history of relapse in AML and CNS should alert oncologists to new clinical trial activity. The selection of patients who should be invited into clinical trials depends on several factors, including their response to treatment regimens and other clinical characteristics of the disease.

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