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Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial.

ABSTRACT: This study tested progesterone for perimenopausal hot flush ± night sweat (vasomotor symptom, VMS) treatment. It was a double-blind, randomized trial of 300 mg oral micronized progesterone@bedtime versus placebo for 3-months (m) after a 1-m untreated baseline during 2012/1-2017/4. We randomized untreated, non-depressed, screen- and baseline-eligible by VMS, perimenopausal women (with flow within 1-year), ages 35-58 (n = 189). Participants aged 50 (± SD = 4.6) were mostly White, educated, minimally overweight with 63% in late perimenopause; 93% participated remotely. The 1° outcome was 3rd-m VMS Score difference. Participants recorded VMS number and intensity (0-4 scale)/24 h on a VMS Calendar. Randomization required VMS (intensity 2-4/4) of sufficient frequency and/or ≥ 2/week night sweat awakenings. Baseline total VMS Score (SD) was 12.2 (11.3) without assignment difference. Third-m VMS Score did not differ by therapy (Rate Difference - 1.51). However, the 95% CI [- 3.97, 0.95] P = 0.222, did not exclude 3, a minimal clinically important difference. Women perceived progesterone caused decreased night sweats (P = 0.023) and improved sleep quality (P = 0.005); it decreased perimenopause-related life interference (P = 0.017) without increased depression. No serious adverse events occurred. Perimenopausal night sweats ± hot flushes are variable; this RCT was underpowered but could not exclude a minimal clinically important VMS benefit. Perceived night sweats and sleep quality significantly improved.

SUBMITTER: Prior JC

PROVIDER: S-EPMC10241804 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial.

Prior Jerilynn C JC Cameron Andrea A Fung Michelle M Hitchcock Christine L CL Janssen Patricia P Lee Terry T Singer Joel J

Scientific reports 20230605 1

This study tested progesterone for perimenopausal hot flush ± night sweat (vasomotor symptom, VMS) treatment. It was a double-blind, randomized trial of 300 mg oral micronized progesterone@bedtime versus placebo for 3-months (m) after a 1-m untreated baseline during 2012/1-2017/4. We randomized untreated, non-depressed, screen- and baseline-eligible by VMS, perimenopausal women (with flow within 1-year), ages 35-58 (n = 189). Participants aged 50 (± SD = 4.6) were mostly White, educated, minimal ...[more]

PMID: 37277418

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Project description:Abstract In the phase 3 REPLENISH trial of postmenopausal women with a uterus, TX-001HR (TherapeuticsMD, Boca Raton, FL), an oral 17β-estradiol-progesterone (E2/P4) softgel capsule, reduced moderate to severe hot flush frequency and severity and improved quality of life outcomes, while protecting the endometrium. The objective of this analysis was to further determine the effects of the E2/P4 capsules versus placebo on vasomotor symptoms (VMS) as assessed by the menopause-specific quality of life (MENQOL) questionnaire. In the REPLENISH trial (NCT01942668), women with moderate to severe hot flushes (≥7/day or ≥50/week) were randomized 1:1:1:1:1 to daily E2/P4 (mg/mg) of 1/100 (FDA approved as BIJUVATM), 0.5/100, 0.5/50, 0.25/50, or placebo (VMS substudy). Other women (with fewer VMS) were randomized 1:1:1:1 to active E2/P4 doses only. Three of the 29 items in the MENQOL questionnaire assess vasomotor symptoms: hot flushes, night sweats, and sweating. The symptoms, if experienced, were rated using a 7-item Likert scale ranging from “Not at all bothered” (score of 2) to “Extremely bothered” (score of 8); if not experienced, the score was 1. Changes from baseline to week 12, and months 6 and 12 in these 3 items were assessed in the overall efficacy population (MITT) and VMS (MITT-VMS) substudy population. Women were randomized to daily doses of E2/P4 (mg/mg) 1/100 (n=415), 0.5/100 (n=424), 0.5/50 (n=421), 0.25/50 (n=424) or placebo (n=151). Participants (mean age of 55 years and mean BMI of 27 kg/m2) were primarily white (65%) or black (32%). Mean baseline scores ranged from 6.7 to 7.4 for hot flushes, 6.1 to 7.1 for night sweats, and 6.0 to 6.9 for sweating. In the MITT population, women treated with all E2/P4 doses had significantly more favorable improvements from baseline in their hot flushes (range of significant mean changes with E2/P4 vs placebo, -2.9 to -4.3 vs -1.9 to -2.7), night sweats (-3.1 to -4.0 vs -2.4 to -3.0) and sweating (-2.8 to -3.6 vs -2.3 to -3.2) scores at week 12, and months 6 and 12 (all, P≤0.002). Similarly, significant improvements from baseline with E2/P4 vs placebo (all, P≤0.030) were observed in the MITT-VMS substudy population for hot flushes (-3.0 to -4.4 vs -1.9 to -2.7), night sweats (-3.3 to -4.4 vs -2.4 to -3.0), and sweating (-3.1 to -4.2 vs -2.3 to -3.2), except for those treated with the lowest E2/P4 dose (0.25 mg E2/50 mg P4) at months 6 and 12 for sweating. In the REPLENISH trial, compared with placebo, postmenopausal women treated with E2/P4 had significant improvements in their hot flushes, night sweats and sweating as assessed by MENQOL. Benefits continued for up to 12 months of treatment. These results with this first oral hormone therapy formulation combining bioidentical estradiol and progesterone in a single capsule are consistent with the primary REPLENISH results demonstrating efficacy for the treatment of moderate to severe vasomotor symptoms in menopausal women with a uterus.

Project description:BackgroundHot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice.MethodsQualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs.ResultsBCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities.ConclusionsBoth healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support.Trial registrationNCT02623374 - Last updated 07/12/2015 on ClinicalTrials.gov PRS.

Project description:BackgroundAndrogen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT.MethodsMANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed.DiscussionMANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice.Trial registrationISRCTN reference 58720120 . Registered 13 December 2022.

Dataset Information

Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial.

Publications

Oral micronized progesterone for perimenopausal night sweats and hot flushes a Phase III Canada-wide randomized placebo-controlled 4 month trial.

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