To Help Women With Endometriosis, Experts Give Nod to Abbott’s Tweaked Drug Trial

Aiming to improve the quality of life of women suffering from endometriosis-related chronic pain, India has given the nod to American drug giant Abbott for conducting phase 3 clinical trials for the tweaked version of ‘dydrogesterone’, News18 has learnt.

The drug trial aims to study the management of endometriosis-related pelvic pain.

India will be the first country to conduct the trials. Currently, the drug is not approved in India or in any other country across the globe.

Close to 2.5 crore Indian women suffer from endometriosis, which impacts their everyday lifestyle. Every four of 100 women suffer from the painful disorder in which tissue similar to the uterine lining grows outside the uterus, in places including the abdomen and pelvic area.

The subject expert committee (SEC), in its meeting on May 25, recommended grant of permission to conduct the Phase III clinical trial and bioequivalence. However, the panel of experts has asked the company to “include more clinical trial sites and the sites should be geographically distributed across the country,” according to the minutes of the meeting, seen by News18.

The committee also suggested that the firm should monitor the size of endometrioma of participating subjects during the clinical trial.

On May 18, Abbott submitted an application to the office of the Drugs Controller General of India (DCGI) — the apex health regulator — seeking permission for the manufacturing and marketing of “dydrogesterone modified release tablets 20 milligrams”.

At present, dydrogesterone tablets (10 mg) are available in India in “immediate release” (IR) format for the indications of progesterone deficiencies, such as the treatment of endometriosis, dysmenorrhoea and secondary amenorrhoea, irregular cycles and dysfunctional uterine bleeding.

It is also used in the treatment of threatened miscarriage and habitual miscarriage apart from hormone replacement therapy.

How will the trial be conducted?

The protocol submitted by the firm, seen by News18, aims to enrol around 230 subjects (115 in each arm) in this study.

“This is a prospective, randomised, single-blind, single-dummy, non-inferiority, two-arm, multicentric study,” said the trial protocol. “Subjects will be randomised (1:1) to receive either Dydrogesterone modified release tablet 20 mg OD or Dydrogesterone 10 mg IR.”

The treatment duration — under the study —for each subject will be three months. The study will enrol women aged between 18 and 45 years who have been diagnosed with endometriosis and chronic pelvic pain.

“The subjects would be provided with patient diaries where they would note details about their daily intake of study drug, any concomitant medications that they take including analgesics, and any treatment emergent adverse events they experience.”

The company has proposed to manufacture the tweaked formulation at the Puducherry-based loan-licensed manufacturing site of Abbott India Ltd.

In the trial protocol, the secondary objective behind the study is to assess the quality of life in subjects with endometriosis treated with dydrogesterone ‘modified’ versus ‘immediate release’ apart from the additional objective of assessing the reduction in the size of endometriosis with both medicines.