Mapeamento do Ciclo Menstrual Durante a Utilização de Administração de Insulina em Circuito Fechado (MCM-Loop)
11 de setembro de 2026 atualizado por: Lia Bally
A hipótese é que a ciclicidade menstrual afeta o metabolismo da glucose e da energia em mulheres com diabetes tipo 1. A fundamentação da hipótese sobre os efeitos do ciclo baseia-se na suposição de que as flutuações das hormonas sexuais femininas ao longo do ciclo menstrual causam alterações nos parâmetros fisiológicos do metabolismo da glucose e da homeostasia da energia e/ou em aspetos do estilo de vida envolvidos na regulação da glicemia e do peso corporal. Espera-se que as flutuações hormonais afetem a sensibilidade à insulina, o esvaziamento gástrico, o comportamento alimentar e o gasto energético. Antecipa-se que a sensibilidade à insulina seja mais elevada na fase pré-ovulatória e mais baixa na fase lútea média. Espera-se ainda que o esvaziamento gástrico atinja o pico na fase folicular, e que o gasto energético e a ingestão alimentar sejam mais elevados durante a fase lútea média.
O objetivo principal deste estudo é caracterizar o metabolismo da glucose e da energia ao longo do ciclo menstrual em mulheres com diabetes tipo 1 e ciclos naturais. Objetivos adicionais são avaliar o impacto do ciclo menstrual no controlo da glucose e nas necessidades de insulina, investigar como as flutuações nos níveis de hormonas sexuais influenciam o metabolismo da glucose e da energia, e quantificar a variabilidade inter e intra-individual nas alterações metabólicas relacionadas com o ciclo menstrual. Além disso, o estudo irá avaliar se alterações nos componentes fisiológicos-chave do metabolismo da glucose e fatores comportamentais medeiam as variações relacionadas com o ciclo menstrual no controlo da glucose e nas necessidades de insulina.
Visão geral do estudo
Status
Concluído
Tipo de estudo
Observacional
Inscrição (Real)
40
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Canton of Bern
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Bern, Canton of Bern, Suíça, 3010
- Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra de Probabilidade
População do estudo
Os participantes elegíveis serão mulheres com idades entre 18 e 45 anos, com um ciclo menstrual natural (que ocorre sem intervenções médicas ou hormonais), que tenham Diabetes Tipo 1 e estejam dispostas a seguir os procedimentos relacionados com o estudo.
Descrição
Critérios de Inclusão:
- Sexo feminino atribuído ao nascimento
- Diabetes tipo 1 há pelo menos 12 meses
- Idade entre 18-45 anos
- Ciclo menstrual natural (que ocorre sem intervenções médicas ou hormonais)
- Terapia com insulina funcional administrada por injeção ou bomba de insulina
- Disponibilidade para seguir os procedimentos relacionados com o estudo
- Disponibilidade para usar contraceção mecânica durante o período de participação no estudo
Critérios de Exclusão:
- Uso de contraceptivos ou intervenções médicas que interfiram com as flutuações hormonais naturais do ciclo menstrual ou com a hemorragia cíclica
- Intervenções que interfiram com o metabolismo da glicose ou da energia (para além da insulina, reposição hormonal da tiroide ou estatinas), conforme avaliado pelo investigador, serão interrompidas durante a duração do estudo, com um período de eliminação adequado antes do início da recolha de dados
- Presença de qualquer condição física ou psicológica, ou qualquer intervenção médica que possa interferir com a realização dos procedimentos e/ou com a sua avaliação, conforme avaliado pelo investigador
- Grávida ou a amamentar
- Participação noutro estudo clínico que interfira com a interpretação dos resultados do estudo, conforme avaliado pelo investigador
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Women with Type 1 Diabetes
Participants with type 1 diabetes from age 18 to 45 years and a natural menstrual cycle will be followed for 3 consecutive menstrual cycles.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time in target glucose range
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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The primary metric for glucose control is the proportion of time with sensor glucose levels in the target range (3.9-10mmol/L, %). Glucose levels will be measured using a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor). |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Oxidação do substrato
Prazo: Avaliado uma vez em cada avaliação específica da fase (folicular precoce, pré-ovulatória e lútea) durante um ciclo menstrual
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A oxidação de substrato (ou seja, quantificada pela contribuição relativa da oxidação de gordura para o gasto energético em repouso) será medida por calorimetria indireta em estado de jejum (≥8 horas) para fornecer contexto adicional como um determinante fisiológico do metabolismo da glucose e da energia.
Este resultado é medido apenas num subgrupo de 15 participantes.
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Avaliado uma vez em cada avaliação específica da fase (folicular precoce, pré-ovulatória e lútea) durante um ciclo menstrual
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Algorithm-directed insulin delivery following a standardized meal
Prazo: The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
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The primary insulin metric is the algorithm-directed insulin dose (units) delivered over a 3 hour period following a standardized meal without a manual bolus.
Insulin delivery is recorded using the mylife CamAPS FX automated insulin delivery system.
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The outcome will be measured at each standardized meal assessment, performed during the three key menstrual cycle phases (early-follicular, pre-ovulatory, and mid-luteal),across three menstrual cycles, resulting in a total of nine 3-hour assessment times
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Insulin sensitivity
Prazo: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Insulin sensitivity will be estimated continuously throughout the study from sensor glucose and insulin pump data, collected via the mylife CamAPS FX automated insulin delivery system, using mathematical modeling.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Gastric emptying
Prazo: The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
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This outcome is based in the [13C]-acetate breath test. Breath 13CO2 enrichment is analyzed using infrared spectrometry and kinetics parameters are derived using mathematical modelling. The main parameter of interest is T50 (ie., the time until half of the ingested meal was absorbed). This outcome is measured only in a subgroup of 15 participants. |
The outcome is evaluated at each phase-specific assessment (early follicular, pre-ovulatory, and luteal) for one menstrual cycle.
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Total energy expenditure
Prazo: Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
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Total energy expenditure will be quantified using the doubly labelled water method.
This outcome is measured only in a subgroup of 15 participants.
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Continuously over one menstrual cycle. Duration varies depending on individual cycle length, ranging from 20 days to 50 days.
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Dietary intake
Prazo: Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
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Total energy intake (kcal/day) will be assessed by recording all meals using an image-based automated food analysis application SNAQ.
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Measured for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days over 3 cycles
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Physical activity
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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The number of steps per day, as a component of physical activity, will be measured using the Garmin Venu 3 smartwatch.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dispêndio energético em repouso
Prazo: Avaliado uma vez em cada fase específica de avaliação (folicular inicial, pré-ovulatória e lútea) durante um ciclo menstrual.
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O gasto energético em repouso (kcal/dia) será medido por calorimetria indireta em estado de jejum (≥8 horas) para fornecer contexto adicional como determinante fisiológico do metabolismo energético.
Este resultado é medido apenas num subgrupo de 15 participantes.
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Avaliado uma vez em cada fase específica de avaliação (folicular inicial, pré-ovulatória e lútea) durante um ciclo menstrual.
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Impacto percebido relatado pelo paciente
Prazo: No final do estudo (após três ciclos menstruais).
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O impacto percebido do ciclo menstrual no controlo e gestão da diabetes será capturado retrospetivamente no final do estudo através de um questionário de experiência.
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No final do estudo (após três ciclos menstruais).
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Postprandial mean glucose
Prazo: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
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Mean postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals.
Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system.
This outcome serves as an additional metric within the overall assessment of glucose control.
Additionally, mean postprandial glucose levels will be specifically measured in the 3 hours following the standardized meal assessment using continuous glucose monitoring.
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The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as at each standardized meal assessment, resulting in a total of nine 3-hour assessment times.
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Postprandial peak glucose
Prazo: The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
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Peak postprandial glucose levels measured using continuous glucose monitoring in the 3 hours following meals.
Meal timepoints defined as manual carbohydrate entries in the mylife CamAPS FX automated insulin delivery system.
This outcome serves as an additional metric within the overall assessment of glucose control.
Additionally, peak postprandial glucose levels will be specifically measuredin the 3 hours following the standardized meal assessment using continuous glucose monitoring.
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The outcome will be evaluated continuously over 3 menstrual cycles (duration varies from 60 days (20-day cycles) to 150 days (50-day cycles)) as well as once for each standardized meal assessment (9 values in total).
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Proportion of time spent in the hyperglycaemic range
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)
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Glucose levels above 10 mmol/L are classified as hyperglycaemic. Glucose levels will be measured using a continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor). This outcome serves as an additional metric within the overall assessment of glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles)
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Proportion of time spent in hypoglycaemic range
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose levels below 3.9 mmol/L are classified as hypoglycaemic.
Glucose levels will be measured using continuous glucose monitoring (Dexcom G6 system or an equivalent CGM sensor) This outcome serves as an additional metric within the overall assessment of glucose control.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - standard deviation
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the standard deviation (SD) of sensor glucose values measured using continuous glucose monitoring. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - coefficient of variation
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the coefficient of variation (CV) of sensor glucose values measured using continuous glucose monitoring data. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability - mean amplitude of glycaemic excursions
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Glucose variability assessed as the mean amplitude of glycaemic excursions (MAGE) derived from continuous glucose monitoring data. This outcome provides an additional metric contributing to the assessment of glucose variability and overall glucose control. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Total daily insulin dose
Prazo: Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Total daily insulin dose (U/day) will be evaluated using the mylife CamAPS FX automated insulin delivery system, which includes a continuous glucose monitoring sensor (Dexcom G6 or an equivalent CGM sensor for participants already using mylife CamAPS FX with a different sensor), an insulin pump (YpsoPump), and the CamAPS FX application.
This outcome serves as an additional measure of individual insulin requirements.
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Over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Basal insulin
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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As an additional measure of insulin requirements, the proportion of basal insulin relative to total insulin delivery (%) will be assessed. It will be measured using the mylife CamAPS FX AID system consisting of a continuous glucose monitoring sensor (Dexcom G6 system or an equivalent CGM sensor if they already use the mylife CamAPS FX AID system with a different sensor), the insuline pump (Ypsopump) and the CamAPS FX app. |
Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Bolus frequency
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Units are (n/day).
The outcome is the number of manual boluses entered into the mylife CamAPS FX AID system.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Model-estimated energy intake
Prazo: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Daily energy intake (kcal/day) will be estimated using an energy balance model based on frequently measured body weight and physical activity data, and, where available, energy expenditure assessed using the doubly labeled water methodology.
This outcome provides a complementary, model-based estimate of energy intake alongside self-reported dietary intake.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Proportion of carbohydrate intake
Prazo: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of carbohydrate intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Proportion of fat intake
Prazo: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of fat intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Proportion of protein intake
Prazo: Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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The proportion of protein intake (% of total energy intake) will be derived from meal records collected using the image-based automated food analysis application (SNAQ), providing complementary information on macronutrient distribution.
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Measured over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Dietary fiber intake
Prazo: Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Dietary fiber intake will be derived from meal records collected using the SNAQ application as an additional component of overall dietary intake assessment.
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Total intake over 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Food category distribution
Prazo: Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Food category distribution will be derived from meal records collected using the SNAQ application, providing complementary information on dietary patterns within overall dietary intake.
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Measured continuously at every meal for 3 days following each phase-specific assessment (early follicular, pre-ovulatory, and luteal) across three menstrual cycles, totaling 27 days from 9 assessments.
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Activity minutes per day
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Active minutes per day will be measured using the Garmin Venu 3 smartwatch as a complementary indicator of physical activity.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Body weight
Prazo: Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Body weight will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Measured daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Fat mass
Prazo: Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Percentage of body fat mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Daily over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Fat-free mass
Prazo: Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Percentage of fat-free mass, as a component of body composition, will be measured using the Garmin Index S2 smart scale to provide additional metabolic context.
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Measured daily over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Beta-hydroxybutyrate levels
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Beta-hydroxybutyrate levels (mmol/L), will be assessed using the SiBio Ketone Sensor to provide additional metabolic context.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate (bpm), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate variability
Prazo: Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Heart rate variability (High and low frequency components or equivalent time domain indices), will be assessed using the Garmin Venu 3 smartwatch to provide a broader metabolic context and as an indicator of autonomic nervous system activity.
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Continuously over 3 menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Patient-reported perceived impact - real-time electronic logs
Prazo: Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Perceived impact of the menstrual cycle on diabetes control and management will be captured additionally in real time using electronic logs in a smartphone app.
Data are considered supplementary to the experience questionnaire-based assessment.
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Continuously over three menstrual cycles. Duration varies depending on individual cycle length, ranging from 60 days (20-day cycles) to 150 days (50-day cycles).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Escalante Pulido JM, Alpizar Salazar M. Changes in insulin sensitivity, secretion and glucose effectiveness during menstrual cycle. Arch Med Res. 1999 Jan-Feb;30(1):19-22. doi: 10.1016/s0188-0128(98)00008-6.
- Charkoudian N, Stachenfeld N. Sex hormone effects on autonomic mechanisms of thermoregulation in humans. Auton Neurosci. 2016 Apr;196:75-80. doi: 10.1016/j.autneu.2015.11.004. Epub 2015 Nov 30.
- Hirshoren N, Tzoran I, Makrienko I, Edoute Y, Plawner MM, Itskovitz-Eldor J, Jacob G. Menstrual cycle effects on the neurohumoral and autonomic nervous systems regulating the cardiovascular system. J Clin Endocrinol Metab. 2002 Apr;87(4):1569-75. doi: 10.1210/jcem.87.4.8406.
- Fede C, Albertin G, Petrelli L, Sfriso MM, Biz C, De Caro R, Stecco C. Hormone receptor expression in human fascial tissue. Eur J Histochem. 2016 Nov 2;60(4):2710. doi: 10.4081/ejh.2016.2710.
- McEwen BS, Milner TA. Understanding the broad influence of sex hormones and sex differences in the brain. J Neurosci Res. 2017 Jan 2;95(1-2):24-39. doi: 10.1002/jnr.23809.
- Mayes JS, Watson GH. Direct effects of sex steroid hormones on adipose tissues and obesity. Obes Rev. 2004 Nov;5(4):197-216. doi: 10.1111/j.1467-789X.2004.00152.x.
- Sherman BM, Korenman SG. Hormonal characteristics of the human menstrual cycle throughout reproductive life. J Clin Invest. 1975 Apr;55(4):699-706. doi: 10.1172/JCI107979.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de maio de 2025
Conclusão Primária (Real)
8 de setembro de 2026
Conclusão do estudo (Real)
8 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
22 de dezembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de março de 2026
Primeira postagem (Real)
17 de março de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCM-Loop
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Os dados individuais dos participantes (IPD) serão disponibilizados mediante pedido fundamentado ao investigador principal.
Prazo de Compartilhamento de IPD
Os dados individuais dos participantes (IPD) estarão disponíveis a partir de 12 meses após a publicação dos resultados do ensaio.
Critérios de acesso de compartilhamento IPD
A aprovação ética, conforme aplicável na legislação suíça, deverá ser obtida por quem solicitar os dados.
Além disso, deve existir um acordo de transferência e processamento de dados para garantir a conformidade com os regulamentos de proteção de dados.
Além disso, deve existir um acordo de transferência e processamento de dados para garantir a conformidade com os regulamentos de proteção de dados.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .