December 2025 brought a wave of important updates that continue to shape the care of women across all stages of life.

In the ever-evolving field of obstetrics and gynecology, noteworthy advancements emerged in cervical health, gonorrhea management, endometriosis knowledge, and more.

In this monthly recap, Contemporary OB/GYN highlights the most impactful regulatory news, clinical research findings, and expert perspectives from December 2025.

Click on each title below for in-depth coverage of these key updates.

1. FDA approves zoliflodacin (Nuzolvence) for uncomplicated gonorrhea

The FDA has approved Nuzolvence (zoliflodacin; Innoviva Specialty Therapeutics), a single-dose oral treatment for uncomplicated urogenital gonorrhea in adults and children aged 12 years and older weighing at least 77 pounds. The approval represents 1 of only 2 new treatment options for this infection in nearly two decades.

Clinical trial data demonstrated that Nuzolvence is non-inferior to current injectable therapy, including for drug-resistant strains, while offering the convenience of a single oral dose. Rising gonorrhea rates and increasing antimicrobial resistance have created a critical need for new therapies, particularly for patients who cannot receive injections or are allergic to first-line antibiotics. Nuzolvence’s distinct mechanism as a bacterial type 2 topoisomerase inhibitor provides an alternative approach, and its approval may expand treatment access and support timely management in diverse clinical settings.

2. American Cancer Society updates cervical cancer screening guidelines

The American Cancer Society (ACS) has updated cervical cancer screening guidelines for average-risk women and individuals with a cervix, incorporating self-collected vaginal specimens for HPV testing and revised criteria for screening discontinuation. Screening should begin at age 25 years, with primary HPV testing every 5 years through age 65 years, while co-testing or cytology-alone testing remains acceptable when primary HPV testing is unavailable.

For the first time, self-collection is considered an acceptable option for primary HPV screening, particularly for individuals facing barriers to clinic-based care, though clinician-collected specimens remain preferred. ACS recommends repeating HPV testing in 3 years for HPV-negative self-collected samples.

Updated guidance clarifies exit criteria, advising negative HPV tests or co-tests at ages 60 and 65 years, or 3 consecutive negative cytology results when HPV testing is unavailable. The guidelines aim to expand access, improve adherence, and support ongoing research and implementation efforts to reduce cervical cancer incidence and address disparities.

3. DARE to PLAY sildenafil cream becomes commercially available for women in select states

Daré Bioscience has launched DARE to PLAY, a topical sildenafil cream designed to enhance genital blood flow and arousal sensations in women, now available by prescription in select states through a Section 503B outsourcing facility. The cream is intended for use as needed during sexual activity and acts locally without systemic effects.

Clinical studies, including a phase 2b randomized trial in premenopausal women with female sexual arousal disorder, demonstrated improvements in arousal sensations and exploratory benefits in desire, orgasm, and sexual distress for select participants. While compounded and not FDA approved, the product is manufactured under current Good Manufacturing Practice standards, with plans for future FDA approval. The availability of DARE to PLAY addresses an unmet need for evidence-based therapies for female sexual arousal, potentially expanding treatment options for approximately 20 million affected women in the United States.

4. How invisible symptoms and provider bias delay endometriosis diagnosis

Health care professionals have emphasized that endometriosis is frequently underrecognized, contributing to diagnostic delays and highlighting the need to address provider bias and preconceptions. A qualitative study explored how clinicians approach diagnosis, using focus groups with general practitioners, nurses, and gynecologists.

Analysis identified 3 main themes: masking and unmasking symptoms, the influence of witnesses on diagnosis, and barriers that hinder timely evaluation. Providers reported that endometriosis pain is often invisible or misattributed to other conditions, making specialist referral critical.

The presence of a partner or corroborating medical documentation was noted to increase the likelihood of recognition and referral. Challenges related to primary care practices, differences between generalist and specialist providers, and interpretations of chronic pelvic pain were also cited as contributing to delays, underscoring the need for awareness and improved diagnostic strategies.

5. Zoliflodacin demonstrated non-inferiority in adults and adolescents with gonorrhea

Innoviva Specialty Therapeutics reported phase 3 trial results showing that oral zoliflodacin is non-inferior to standard combination therapy with ceftriaxone and azithromycin for treating uncomplicated urogenital gonorrhea in adults and adolescents. Conducted across multiple countries, the randomized study enrolled 930 participants and demonstrated comparable microbiological cure rates at urogenital and extragenital sites, with similar safety profiles and no serious adverse events.

Rising antimicrobial resistance in Neisseria gonorrhoeae underscores the need for new oral treatment options, as ceftriaxone remains the only recommended first-line therapy in the United States. Zoliflodacin, a first-in-class DNA gyrase inhibitor, has received FDA Qualified Infectious Disease Product designation, with regulatory review ongoing, and may provide a single-dose oral alternative for patients, including those with limited access to injectable therapy or resistant infections.