The Women's Health CRO
hVIVO is a specialist in women's health clinical studies, offering a broad spectrum of pharmacodynamic, endocrine, and reproductive assessments across conditions including polycystic ovary syndrome (PCOS), endometriosis, uterine fibroids, premenstrual dysphoric disorder (PMDD), perimenopause, menopause and vasomotor symptoms, post-menopausal osteoporosis, and female-predominant autoimmune, migraine, and cardiometabolic disease. Supported by a dedicated Berlin clinical research unit specialised in women's health and 40+ years of scientific leadership in clinical pharmacology, hVIVO delivers evidence-led support spanning PK/PD consultancy and full-service clinical operations across the female lifespan.
- Specialists in women's health clinical research, with long-standing expertise across reproductive, endocrine, and post-menopausal patient populations
- Comprehensive pharmacology and diagnostic capabilities, including metabolic monitoring, endocrine and hormonal assessments, cycle-tracking and hormonal phase stratification
- Specialist Berlin clinical research unit (26 beds, 18 intensive monitoring) purpose-built for women's health studies
- In-house recruitment, screening, and referrals from a 400,000+ participant database across the UK and Germany
Scientific & Technical Capabilities
Endocrine & Hormonal Assessments
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Estradiol, progesterone, FSH, LH profiling
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Anti-Müllerian hormone (AMH) testing
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Androgen panel (testosterone, DHEA-S, SHBG)
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Cycle-phase stratification and tracking
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Cortisol and thyroid function assessments
Reproductive & Gynaecological Assessments
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Transvaginal and pelvic ultrasound
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Antral follicle count
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Endometrial thickness monitoring
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Pelvic pain and quality-of-life PROs
- Menstrual diary and symptom tracking
Metabolic & Cardiovascular Function
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Oral Glucose Tolerance Testing (OGTT)
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Continuous glucose monitoring
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Insulin resistance (HOMA-IR) assessments
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Lipid profile and inflammatory markers
- Blood pressure and vascular function
Bone & Body Composition
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DXA scanning for bone mineral density
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Body composition (fat mass / lean mass)
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Bone turnover markers (CTX, P1NP)
- Fracture risk assessment
Biomarker Assessments
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Hormonal biomarkers
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Inflammatory cytokines
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Reproductive biomarkers
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Pharmacogenetic profiling
Indications
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Polyendocrine Metabolic Ovarian Syndrome (PMOS)
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Endometriosis
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Uterine fibroids and heavy menstrual bleeding
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PMDD and severe PMS
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Menopause and vasomotor symptoms
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Post-menopausal osteoporosis
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Genitourinary syndrome of menopause (GSM)
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Female sexual dysfunction / HSDD
Special Population and Patient Experience
Special Populations
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Female cohorts across the reproductive lifespan
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Post-menopausal women
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Perimenopausal women
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Pharmacogenetic Normal, Intermediate, Excessive Metabolisers
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Renal Impairment
- Hepatic Impairment
Patient Populations
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PCOS
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Endometriosis
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Uterine fibroids
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PMDD / severe PMS
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Menopause and vasomotor symptoms
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Post-menopausal osteoporosis
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Female-predominant autoimmune disease
- Hormonal migraine
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hVIVO provides a panel of endocrine, reproductive, metabolic, and cardiovascular pharmacodynamic assessments for women's health clinical trials, from First-in-Human through Proof-of-Concept.
Yes. Depending on the patient population and sample size, hVIVO can deliver PoC trials as single or multi-site studies across our UK and Germany network, or act as a specialist site within a sponsor's existing CRO arrangement.
hVIVO offers transvaginal and pelvic ultrasound, DXA scanning for bone mineral density, antral follicle counts, endometrial thickness monitoring, and integrated biomarker assessment.
Yes. Drug–drug interaction and food-effect studies — including those involving hormonal contraceptives — are part of our standard clinical pharmacology offering and a regulatory expectation for most new drugs developed in women of reproductive potential.
Yes. hVIVO has established experience running gender trials in female and post-menopausal populations, supported by a 400,000+ participant database and 1,000+ weekly screening capacity.
Plan your next Women's Health Trial with hVIVO
If you're a potential customer, find out how hVIVO can help you.