What is the use of Diane 35?

October 6, 2025 •

3 min read

Diane 35 is a medication that contains the hormones cyproterone acetate and ethinylestradiol, primarily used to treat women with moderate to severe androgen-related conditions, according to prescribing information. Its dual-action formula addresses issues like acne and hirsutism while also providing a contraceptive effect.

Quick Summary

Diane 35 is a combined hormonal medication for women of reproductive age. It is used to treat androgen-related symptoms, including severe acne and hirsutism. The drug also acts as an effective oral contraceptive but is not recommended for contraception alone due to its risk profile.

Key Points

Treats Androgen-Related Conditions: Diane 35 is primarily used to treat moderate to severe acne, hirsutism (excessive hair growth), and symptoms of polycystic ovary syndrome (PCOS) in women caused by androgen sensitivity.
Not for Contraception Only: Due to its risk profile, Diane 35 should not be used solely for birth control. Its contraceptive effect is a secondary function when used for its primary purpose.
Dual-Hormone Action: The medication combines cyproterone acetate, a potent anti-androgen, and ethinylestradiol, an estrogen. Together, they block androgen effects and suppress ovulation.
Increased Blood Clot Risk: Users of Diane 35 have a higher risk of developing blood clots (venous and arterial thromboembolism) compared to non-users or those on some other oral contraceptives.
Considered a Second-Line Treatment: For acne and hirsutism, Diane 35 is typically only prescribed after other less risky treatments, such as topical therapies or other contraceptives, have failed.

Diane 35, also known as co-cyprindiol, is a prescription medication combining the anti-androgen cyproterone acetate and the estrogen ethinylestradiol. It is indicated for women with androgen-dependent conditions that haven't responded to other treatments. While it treats visible symptoms like skin and hair issues, it also offers contraception. However, due to its profile and risks, it requires strict medical supervision and isn't a first-line treatment.

The Primary Uses of Diane 35

Treating Androgen-Related Conditions

Diane 35 targets conditions in women caused by excessive androgens or sensitivity to them. These include:

Severe Acne: Often prescribed for moderate to severe acne unresponsive to other treatments, showing significant improvement in studies.
Hirsutism: Reduces excessive hair growth on the face, chest, and back by counteracting androgen effects.
Polycystic Ovary Syndrome (PCOS): Helps regulate hormone levels in women with PCOS experiencing symptoms like acne, hirsutism, and irregular periods due to hyperandrogenism.

The Contraceptive Function

Diane 35 also effectively prevents pregnancy by inhibiting ovulation, thickening cervical mucus, and thinning the uterine lining. However, it should not be used solely for birth control due to its higher risk profile compared to other contraceptives.

Mechanism of Action: How Diane 35 Works

Cyproterone Acetate (CPA): This anti-androgen blocks androgen receptors and suppresses ovarian androgen production.
Ethinylestradiol (EE): This estrogen increases sex hormone-binding globulin (SHBG), which binds to free androgens, reducing their impact. EE also helps suppress ovulation.

Important Considerations and Risks

Significant risks and contraindications are associated with Diane 35:

Venous Thromboembolism (VTE): Increased risk of blood clots, potentially leading to DVT or PE, higher than with some other contraceptive pills, especially in the first year.
Arterial Thromboembolism: Also increases risk of arterial clots, raising the chance of heart attack or stroke, particularly in women with existing risk factors.
Liver Tumors: Rare reports of benign and malignant liver tumors in users of hormonal contraceptives like Diane 35.
Meningioma: Higher doses of cyproterone acetate increase the risk of this non-cancerous brain tumor.
Contraindications: Should not be used by women with a history of blood clots, severe liver disease, certain cancers, uncontrolled high blood pressure, or severe diabetes with vascular issues.

Comparison of Diane 35 and Alternative Treatments


Feature	Diane 35 (Cyproterone Acetate/Ethinylestradiol)	Drospirenone-Based Pills (e.g., Yaz)	General Combined Oral Contraceptives (COCs)	Other Options (IUDs, non-hormonal)
Anti-androgenic Potency	High, particularly effective for severe hirsutism and acne.	Moderate; effective for mild to moderate androgenic symptoms.	Varies depending on the progestin used; some are more androgenic.	Not applicable; no hormonal effect.
Contraceptive Effectiveness	Highly effective when taken correctly, over 99% with perfect use.	Very effective, >99% with perfect use.	Very effective, >99% with perfect use.	Highly effective options exist (e.g., hormonal IUD), but lower efficacy rates are possible with user-dependent methods.
Risk of Venous Thromboembolism (VTE)	Increased risk, estimated at 1.5 to 2 times higher than levonorgestrel-containing COCs.	Increased risk; similar or slightly lower than Diane 35, higher than older COCs.	Varies based on formulation; older 'second-generation' pills (levonorgestrel) have lower risk.	Copper IUDs have no VTE risk. Hormonal IUDs and injections may have minimal risk.
Ideal Use Case	Severe androgenic symptoms unresponsive to other treatments, and contraception is required.	Management of mild to moderate acne, hirsutism, and PCOS symptoms.	General contraception and management of moderate menstrual symptoms.	Women with contraindications to hormonal contraception or those who prefer non-hormonal methods.

Conclusion

Diane 35 is specifically used to treat severe, hormonally driven conditions in women like refractory acne, hirsutism, and certain PCOS symptoms. Its anti-androgenic and contraceptive effects make it valuable when other treatments fail. However, the increased risk of blood clots necessitates informed patient consent and careful monitoring. Since it's not for contraception alone, doctors must weigh benefits and risks, as safer alternatives may be suitable for some patients.

Frequently Asked Questions

Diane 35 is used to treat women with moderate to severe acne and/or hirsutism (excessive hair growth) related to androgen sensitivity. It is also prescribed for some symptoms of Polycystic Ovary Syndrome (PCOS). When used for these purposes, it also acts as an effective oral contraceptive.

The active ingredient cyproterone acetate blocks androgen receptors and suppresses ovarian androgen production. The ethinylestradiol component increases sex hormone-binding globulin (SHBG) levels, which bind to free-circulating androgens. This combined action reduces the hormonal effects that cause acne and excessive hair growth.

Yes, Diane 35 provides effective oral contraception by inhibiting ovulation and altering cervical mucus and the uterine lining, but it should not be used for birth control alone due to an elevated risk of blood clots compared to other contraceptive options.

The most significant risk is an increased chance of venous and arterial thromboembolism (blood clots). Other risks include potential liver issues and benign brain tumors (meningiomas at higher doses).

Treatment length depends on symptom severity and should be reviewed periodically. It's usually stopped 3-4 cycles after symptoms resolve, but can be restarted if symptoms return, under a doctor's guidance.

Women with a history of blood clots, severe liver disease, certain cancers, uncontrolled high blood pressure, severe diabetes with vascular complications, or known hypersensitivity should avoid Diane 35.

Diane 35 has a higher blood clot risk than many other treatments. It's typically used for acne that hasn't responded to safer options like topical treatments or less risky oral contraceptives.