Study of Progesterone in Treatment of Vasomotor Symptoms

NCT03202186 | Terminated Phase 3

• 1 other identifier: BHR-401-301
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be tested against placebo in hierarchical order, starting with the highest dose. Superiority will be defined as a significant (significance level α = 0.05) reduction of moderate to severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint of the study).

Conditions

Menopause Related Conditions

Outcome Measures

Primary Outcomes (1)

• Frequency of moderate to severe vasomotor symptoms at 12 weeks

  the change vs. baseline of the frequency of moderate or severe VMS episodes (per day) after 12 weeks of treatment with BHR-401or placebo

  12 weeks

Secondary Outcomes (3)

• Frequency of moderate to severe vasomotor symptoms at 4 weeks

  4 weeks

• Severity of vasomotor symptoms at 12 weeks

  12 weeks

• Severity of vasomotor symptoms at 4 weeks

  4 weeks

Other Outcomes (3)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  12 weeks

• Kupperman Index

  4 and 12 weeks

• Sleep quality assessed by means of the Pittsburgh Sleep Quality Index (PSQI)

  4 and 12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

oral administration of Placebo capsule

Drug: Placebo oral capsule

Progesterone 200 mg

EXPERIMENTAL

oral administration of progesterone 200 mg

Drug: Progesterone oral capsule

Progesterone 300 mg

EXPERIMENTAL

oral administration of progesterone 300 mg

Drug: Progesterone oral capsule

Progesterone 400 mg

EXPERIMENTAL

oral administration of progesterone 400 mg

Drug: Progesterone oral capsule

Interventions

Progesterone oral capsule DRUG

Oral capsule treatment

Progesterone 200 mg; Progesterone 300 mg; Progesterone 400 mg

Placebo oral capsule DRUG

Oral capsule treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Adult (≥ 18 years), postmenopausal women, where postmenopause is defined as
• at least 12 months of spontaneous amenorrhea, or
• months of spontaneous amenorrhea and follicle stimulating hormone (FSH) levels \> 40 mIU/ml, or
• status at least 6 weeks after bilateral oophorectomy with or without hysterectomy
• Non-smoker
• Mammography without pathological findings obtained within routine medical care no longer than 12 months prior to screening visit
• Cervical smear (Papanicolaou test) without pathological findings (i.e. \< III) obtained no longer than 12 months prior to screening visit
• In addition subjects need to fulfil the following criterion in order to be randomized (i.e. to enter the treatment period):
• A minimum of 50 moderate to severe VMS episodes over the last 7 consecutive days prior to the baseline visit, as documented in the patient diary.

You may not qualify if:

• Use of any hormone replacement therapy (including phytoestrogens and other plant-derived sex hormones) during the previous 12 weeks prior to screening
• Ongoing or suspicion of any estrogen-dependent malignancy.
• Endometrial thickness ≥ 5 mm at screening visit
• Any history or current presence or suspicion of breast cancer, including carcinoma in situ and other pre-cancerous conditions
• Active malignant disease of any organ system (except for basal localized basal cell carcinoma of the skin) or history thereof in the last 5 years prior to screening visit
• Vaginal bleeding due to unidentified reason within 6 weeks prior to screening
• Ongoing venous thromboembolic event or history thereof within 12 months prior to screening visit
• Known severe renal insufficiency (defined as glomerular filtration rate, GFR \< 30 mg/min/1.73 m²) at screening visit
• Known lipid metabolism disturbances of genetic origin (e.g. familial hypercholesterolemia, familial hypertriglyceridemia)
• Acute or chronic liver diseases or a history of liver disease with liver enzymes having not normalized since then
• Severe disturbances of hepatic function (including porphyria), hepatic tumors, also in medical history
• Rotor syndrome or Dubin-Johnson syndrome
• History of icterus or generalized pruritus during a previous pregnancy
• History of myocardial infarction, stroke or transient ischemic attack or severe cardiac disease, including symptomatic chronic heart failure
• Ongoing major depression

Sponsors & Collaborators

• BHR Pharma, LLC: lead

Study Sites (1)

Fachärztin für Gynäkologie und Geburtshilfe

Bernburg, Germany

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Head of Clinical Development, PhD

  BESINS Healthcare Ireland Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled parallel arm study for 12 weeks

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 28, 2017
• Study Start: August 1, 2017
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)