PMOS Research: Advancing Women's Health Through Clinical Innovation

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. At hVIVO, we support pharmaceutical and biotech companies in designing and delivering rigorous clinical trials that address the full biological, metabolic, and psychosocial complexity of this condition.

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hVIVO PCOS/PMOS Clinical Research

We are leading clinical research experts in PCOS/PMOS and other women's health conditions, dedicated to transforming the treatment landscape through pioneering research and rigorous clinical trials. Polycystic Ovary Syndrome (PCOS) — now increasingly referred to as Polyendocrine Metabolic Ovarian Syndrome (PMOS) — is a common yet complex hormonal disorder affecting women of reproductive age worldwide. It involves elevated levels of androgens, infrequent or prolonged menstrual cycles, and a broad spectrum of metabolic and reproductive consequences.

Join us in advancing women's health through innovative solutions, comprehensive diagnostics, and evidence-based clinical research.

  • End-to-end clinical trial expertise spanning hormonal, metabolic, reproductive, dermatological, and psychological outcomes.
  • Rigorous diagnostic assessments and comprehensive hormone profiling, supported by partnerships with leading central laboratories.
  • Multidisciplinary approach covering both healthy subjects and patient populations across a broad range of women's health conditions.
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The hVIVO PCOS/PMOS Research Service

Who This Service is For

We support biotech startups, specialty pharma, and academic research institutions seeking to develop or advance therapies targeting PCOS/PMOS and related women's health conditions — including endometriosis, hormone replacement, fertility disorders, heavy menstrual bleeding, postmenopausal conditions, sexual dysfunction, uterine fibroids, and in vitro fertilisation. Sponsors rely on our specialist expertise, rigorous diagnostic infrastructure, and multidisciplinary clinical teams to design and deliver studies that generate robust, regulatory-aligned evidence.

What This Service Is

Our PCOS/PMOS Clinical Research service provides scientifically grounded, patient-centred guidance from early-phase studies through to proof-of-concept and confirmatory trials. We specialise in PCOS/PMOS and related conditions, conducting clinical trials backed by comprehensive diagnostic assessments and advanced hormone profiling. We proudly collaborate with certified central laboratories for standardised safety assessments and a broad spectrum of hormone assays, and maintain specialised partnerships for PAP smear analysis and endometrial histology evaluation.

Our Capabilities

Our comprehensive PCOS/PMOS clinical research capabilities include:

  • Gynaecological examination and transvaginal ultrasound for follicular morphology and ovarian volume assessment
  • Vaginal cytology, endometrial biopsy, and histological analysis
  • Insler Score and Hoogland Score assessments for cervical mucus and follicular response evaluation
  • Monitoring of follicular growth and ovulation through serial ultrasound protocols
  • Comprehensive hormone assay panels including AMH, LH/FSH ratio, free androgen index, and insulin sensitivity markers
  • Rating scales and questionnaires assessing quality of life, sleep quality, pain levels, and psychological wellbeing (PCOSQ, PHQ-9, GAD-7)
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Why Choose hVIVO?

Our commitment extends to developing and testing innovative therapies that address PCOS/PMOS symptoms effectively and comprehensively. From early-phase trials to proof-of-concept studies, we employ a multidisciplinary approach — bringing together gynaecologists, endocrinologists, reproductive medicine specialists, and patient engagement experts — to improve patient outcomes and quality of life. We maintain a strong network of specialist referral gynaecologists alongside our in-house board-certified clinical team, ensuring thorough patient evaluations and precise trial protocols at every stage of development. Partner with us to make a meaningful difference in one of women's health's most complex and underserved conditions.
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What sets us apart for women's health research

CRO selection for women's health programmes is not only about capacity. It requires clinical credibility, specialist populations, regulatory literacy across multiple jurisdictions, and a team that understands the complexity of these indications.

1 Dedicated women's health clinical expertise
Our Berlin partner unit has a documented track record in women's health pharmacological trials, with experienced investigators and monitoring infrastructure calibrated for hormonal, endocrine, and reproductive study designs.

2 Cross-indication capability
Women's health conditions frequently intersect with cardiometabolic, immunological, and endocrine pathways. hVIVO's experience across these adjacent areas is a direct asset for complex programme design.

3 Established client base across pharma and biotech
Seven of the world's ten largest biopharma companies are repeat clients. hVIVO also has dedicated sector capability for start-ups and emerging biotechs, including a Speed to Clinic Accelerator and Investor Readiness Consulting service.

4 EMA-compliant infrastructure across UK and Europe
For sponsors seeking European regulatory pathways for women's health programmes, hVIVO's German sites offer EMA-aligned GCP delivery with direct access to university hospital networks and specialist patient populations.

FAQ

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We support programmes from early discovery through Phase II and beyond, including proof-of-concept studies, biomarker qualification trials, ovulation induction studies, and long-term cardiometabolic outcome trials.

Yes. We have expertise in designing stratified trial protocols that account for the four Rotterdam phenotypes and emerging endotype classifications, ensuring results are generalisable across the heterogeneous PCOS/PMOS population.
Yes. Our regulatory affairs team provides scientific advice preparation, pre-IND/pre-CTA meeting support, and guidance on endpoint selection and trial design in alignment with FDA and EMA regulatory frameworks for women's health indications.
Yes. We support pharmacological programmes including insulin sensitisers, GLP-1 receptor agonists, anti-androgens, ovulation induction agents, and novel mechanism-of-action compounds, as well as lifestyle, nutraceutical, and combination intervention trials.
We combine clinic-based recruitment with community outreach, digital health platforms, and partnerships with patient advocacy organisations to ensure diverse, well-characterised trial populations — including underrepresented ethnic groups and adolescent cohorts where appropriate.
Yes. We strongly advocate for and routinely incorporate validated PRO instruments — including the PCOSQ, PHQ-9, GAD-7, and SF-36 — as secondary or co-primary endpoints in all major PCOS/PMOS intervention trials.

Contact Our Women's Health Team

If you are planning a trial talk to our team today.

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