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Therapeutic Expertise

Gynaecology

Our women’s health team runs trials across gynaecology and reproductive medicine — menopause, endometriosis, contraception, PCOS and gynaecologic oncology — with careful attention to validated symptom endpoints and recruitment.

MenopauseEndometriosisContraceptionPCOS

Women’s health trials rely on validated symptom diaries and patient-reported outcomes, and often require thoughtful recruitment and retention strategies. We design protocols with robust endpoint capture and patient-centric, decentralised elements to improve participation.

Addressing common pain points in gynaecology clinical trials

Symptom-based endpoint reliability

Menopause and endometriosis endpoints depend on subjective symptom diaries.

Gynaecology solution — Validated ePRO capture

We use validated electronic diaries and adherence prompts to improve data quality.

Recruitment and retention

Women’s health trials can face recruitment and long-duration retention challenges.

Gynaecology solution — Patient-centric, decentralised models

We apply DCT elements and engagement programmes to widen access and sustain participation.

Nuanced safety monitoring

Hormonal and reproductive therapies require careful, indication-specific safety oversight.

Gynaecology solution — Physician-led monitoring

Our physicians design indication-specific safety monitoring plans.

Resources

Gynaecology clinical trial resources

Ovarian Cancer — From Epidemiology to Enhancing Clinical Trial Design

Design strategy in gynaecologic oncology.

Menopausal Insomnia Clinical Trials

Endpoint considerations in menopause-related trials.

Evidence & insights

Gynaecology white papers

Open-access reports from our physicians and data science teams — free, no sign-in.

Browse all 54 white papers →

The iNGENū CRO difference

Australian expertise, direct FDA submission

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.

“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”

Giles MossChief Executive Officer

Ready to discuss your Gynaecology clinical trial?

Talk to our team about how iNGENū CRO can accelerate your research.

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