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Women's Health Studies

Specialists in Women's Health Research

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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

  • Estradiol, progesterone, FSH, LH profiling

  • Anti-Müllerian hormone (AMH) testing

  • Androgen panel (testosterone, DHEA-S, SHBG)

  • Cycle-phase stratification and tracking

  • Cortisol and thyroid function assessments

Reproductive & Gynaecological Assessments

  • Transvaginal and pelvic ultrasound

  • Antral follicle count

  • Endometrial thickness monitoring

  • Pelvic pain and quality-of-life PROs

  • Menstrual diary and symptom tracking

Metabolic & Cardiovascular Function

  • Oral Glucose Tolerance Testing (OGTT)

  • Continuous glucose monitoring

  • Insulin resistance (HOMA-IR) assessments

  • Lipid profile and inflammatory markers

  • Blood pressure and vascular function

Bone & Body Composition

  • DXA scanning for bone mineral density

  • Body composition (fat mass / lean mass)

  • Bone turnover markers (CTX, P1NP)

  • Fracture risk assessment

Biomarker Assessments

  • Hormonal biomarkers

  • Inflammatory cytokines

  • Reproductive biomarkers

  • Pharmacogenetic profiling

Indications

  • Polyendocrine Metabolic Ovarian Syndrome (PMOS)

  • Endometriosis

  • Uterine fibroids and heavy menstrual bleeding

  • PMDD and severe PMS

  • Menopause and vasomotor symptoms

  • Post-menopausal osteoporosis

  • Genitourinary syndrome of menopause (GSM)

  • Female sexual dysfunction / HSDD

Special Population and Patient Experience

Special Populations

  • Female cohorts across the reproductive lifespan

  • Post-menopausal women

  • Perimenopausal women

  • Pharmacogenetic Normal, Intermediate, Excessive Metabolisers

  • Renal Impairment

  • Hepatic Impairment

Patient Populations

  • PCOS

  • Endometriosis

  • Uterine fibroids

  • PMDD / severe PMS

  • Menopause and vasomotor symptoms

  • Post-menopausal osteoporosis

  • Female-predominant autoimmune disease

  • Hormonal migraine

Explore Women's Health In-Depth

PCOS-PMOS

Affecting more than 170 million women worldwide, Polyendocrine Metabolic Ovarian Syndrome (PMOS) — formerly known as PCOS — remains one of the most undertreated endocrine conditions in women's health.

Endometriosis

 We are dedicated to revolutionizing treatment approaches for women affected by endometriosis. Our biostatistics and methodology specialists support clinical programs from early development through all study phases 

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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.