Neuropeptide Treatment for Hot Flushes During the Menopause

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause

NCT06206408

Hot Flashes

COMPLETED PHASE3

Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With Menopause

NCT00314964

Hot Flashes

COMPLETED PHASE2

A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause

NCT06385795

Menopause Syndrome Menopause Hot Flashes

COMPLETED PHASE2

A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause

NCT06206421

Hot Flashes

ACTIVE_NOT_RECRUITING PHASE3

A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)

NCT01015677

Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist

Aims:

To investigate whether an NK3R antagonist can reduce menopausal flushing

Treatment:

4 weeks administration of active drug and placebo in random order

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopausal Flushing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active drug first

Baseline period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Washout period - 2 weeks Matched placebo orally bd - 2 weeks Monitoring period - 2 weeks

Group Type EXPERIMENTAL

NK3R antagonist - AZD4901

Intervention Type DRUG

Neurokinin 3 receptor antagonist

Placebo

Baseline period - 2 weeks Matched placebo orally bd - 2 weeks Washout period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Monitoring period - 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NK3R antagonist - AZD4901

Neurokinin 3 receptor antagonist

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nil others nil others

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Menopausal women (≥12 months since last menstrual period or bilateral oophorectomy or with a follicle stimulating hormone (FSH) level ≥20 milli-international units/millilitre (mIU/mL) and an estradiol level \<190pmol/l in the absence of a reliable menstrual marker (hysterectomy with ovarian preservation or endometrial ablation)) aged 40-62 years with \>7 hot flushes/day some of which are reported as severe or bothersome who have not been on treatment for menopausal symptoms for the preceding 8 weeks.

Exclusion Criteria

1. Significant illness, as judged by the Investigator, within 2 weeks of first study visit.
2. Volunteer has clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension (defined as systolic blood pressure of ≥ 160 mmHg and/or diastolic blood pressure of ≥100 mmHg); uncontrolled diabetes; or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator.
3. Participant has a history of Gilbert's syndrome, infectious hepatitis, or other significant hepatic disease (e.g. chronic hepatitis, cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or hereditary liver disease) in the opinion of the Investigator.
4. Participant has a history of surgery which in the opinion of the investigator could cause malabsorption (e.g. gastric or small intestinal surgery or gastric bypass surgery or banding), or patient has a disease that causes malabsorption.
5. Clinically significant abnormal ECG and/or abnormalities in ECG at screening as judged by the Investigator.
6. A marked prolongation of QT/corrected QT (QTc) interval (e.g. repeated demonstration of a QTc interval \> 450 ms).
7. Confirmed history of ischaemic heart disease.
8. Past (within 1 year of enrollment) or present alcohol or substance abuse
9. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 3 months of the first administration of AZD4901 in this study. The period of exclusion begins 3 months after the final dose. (Note: patients consented and screened, but not randomised in a previous study are not excluded.)
10. Participant has a history of neoplastic disease within 5 years prior to signing informed consent or is currently on ongoing treatment to prevent cancer recurrence.
11. Involvement in the planning and/or conduct of the study (applies to any AstraZeneca employee and their close relatives and/or staff at the study site directly involved in the study, regardless of their role in accordance with their internal procedures)
12. Inability to understand or cooperate with the requirements of the study
13. Participant is legally or mentally incapacitated
14. Participant has significant psychiatric disease or treatment for psychiatric disease e.g. selective serotonin re-uptake inhibitors (SSRIs) which in the opinion of the Investigator may influence the results of the study.
15. Participant has abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality according to the Investigator:

* Aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 1.5 times ULN
* Total bilirubin \>1.5 times ULN
* Serum creatinine \>2.0 times ULN
16. Clinically relevant disease and abnormalities (past or present), which in the opinion of the Investigator, may either put the patient at risk to participate in this study or may influence the results of the study or the patient's ability to participate in the study.
17. Participant has a history of hyperthyroidism or hypothyroidism or abnormal screening thyroid tests, as judged by the Investigator. Patients with hypothyroidism who are stable on treatment with normal thyroid function tests may be included in the study if in the opinion of the Investigator this will not influence the results of the study.
18. Participant has seizures, patients with history of seizures or with conditions that increase the risk of seizures.
19. Participant has a history of hypersensitivity to more than 2 chemical classes of drugs, including prescription and over-the-counter medications.
20. Participant has taken any potent or moderate CYP3A4 or CYP2C9 inhibitors, potent or moderate CYP3A4 or CYP2C9 inducers, hormonal contraceptives, antiandrogenic drugs, or other medications specified for the time frame

Minimum Eligible Age

40 Years

Maximum Eligible Age

62 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes