Dydrogesterone-Only HRT Returns After 17 Years, Offering Predictable Bleeding Patterns and Enhanced Endometrial Protection

What Happened

Gedeon Richter UK has launched Nalvee (10 mg dydrogesterone)—a progestogen-only tablet—marking the return of a dydrogesterone-only formulation for hormone replacement therapy (HRT) after a 17-year absence in the UK.

Nalvee is offered to clinicians as an option for non-hysterectomised women on estrogen therapy, intended to protect the endometrium without requiring combined progestogens or higher doses.

This product is a branded generic of a formulation first introduced in 1961, previously withdrawn from the UK market in 2008 due to declining HRT use.

Why It Matters

Progestogens are essential in HRT regimens to protect the uterine lining (endometrium) when estrogen is used in women who still have a uterus. The reintroduction of a dydrogesterone-only option gives prescribers and women more flexibility in tailoring hormonal therapy.

Dydrogesterone is believed to mimic natural progesterone more closely than some synthetic progestogens and is highly bioavailable. The 10 mg dose reportedly provides endometrial protection in 97% of women.

One of the common reasons women discontinue HRT is unpredictable or heavy bleeding. Clinicians believe Nalvee’s more favorable, predictable bleeding profile may improve adherence and satisfaction.

What This Means for Women in Perimenopause & Menopause

For women receiving estrogen therapy who still have a uterus, the availability of a progestogen-only option like Nalvee can influence decisions about which HRT regimen to use.

If you’ve avoided or discontinued HRT because of side effects from progestogens (such as mood symptoms, bloating, or irregular bleeding), Nalvee may offer a gentler alternative—though individual response will vary.

Because this is a UK launch, U.S. women won’t yet have direct access—but this development signals broader momentum in refining HRT options globally, which could eventually influence international offerings.

Access & Availability

• UK: Nalvee is now launched in the UK market.
• Other Countries: The product remains available elsewhere, but its return in the UK is significant given its prior absence.
• Prescription: It is intended for use in combination with estrogen in non-hysterectomised women.

Benefits & Risks

Benefits

• Offers a progestogen-only HRT option, without needing more complex or synthetic progestogens.
• Dydrogesterone is bioavailable and designed to act at low doses, potentially reducing side effects.
• Its predictable bleeding profile may reduce the disruptive irregular bleeding that leads many women to stop HRT.

Risks & Considerations

• As with all hormonal treatments, individual risks depend on health history (e.g. breast cancer risk, cardiovascular risk).
• Even though the safety profile is well established from historical use, updated long-term safety data in modern HRT contexts may still be needed.
• Not all women metabolize progestogens similarly; what is tolerable for one may not be for another.

Next Steps / What to Watch For

• Monitoring real-world data and post-marketing safety in the UK to confirm tolerability and adherence benefits.
• Comparative studies between Nalvee and other progestogens (e.g. micronized progesterone, synthetic progestins) on side effects, bleeding, and patient satisfaction.
• Regulatory consideration in other markets—will this formulation be introduced outside the UK?
• Guidance from menopause societies and HRT protocols on when and how best to use Nalvee.

What This Means for Your Midlife Health

The re-entry of a dydrogesterone-only progestogen offers a welcome expansion in HRT options, reinforcing that hormone therapy is not one-size-fits-all. For women in midlife considering or using HRT, this means more room for personalized care—for better balance between benefits and side effects.

Further Reading

If you’re curious to dive deeper, check out:

PharmaTimes: Gedeon Richter Launches Nalvee in UK to Expand HRT Options for Menopause