Around 25 million Indian women are suffering from endometriosis, which affects their everyday lifestyle. (Image: Shutterstock / File)
The protocol submitted by the firm, seen by News18, aims to enroll around 230 subjects (115 in each branch) in this study. Experts ask the company to include more clinical trial sites distributed across the country
With an aim to improve the quality of life of women suffering from chronic pain related to endometriosis, India has approved US pharmaceutical company Abbott to conduct Phase 3 clinical trials for a modified version of ‘dydrogesterone’ , News18 has learnt.
The aim of the drug trial is to study the management of pelvic pain related to endometriosis.
India will be the first country to conduct the test. Currently, the drug is not approved in India or any other country across the world.
Around 25 million Indian women are suffering from endometriosis, which affects their everyday lifestyle. One in four women in 100 suffer from the painful disorder in which tissue similar to the lining of the uterus begins to grow outside the uterus, in places including the abdomen and pelvic region.
The Subject Expert Committee (SEC) in its meeting on May 25 recommended allowing the conduct of Phase III clinical trials and bio-similarity. However, according to the minutes of the meeting accessed by News18, the panel of experts has asked the company to “induct more clinical trial sites and the sites should be geographically distributed across the country”.
The committee also suggested that the firm should monitor the size of the endometriomas of participants taking part in the clinical trial.
On 18 May, Abbott submitted an application to the office of the Drugs Controller General of India (DCGI) – the apex health regulator – asking for permission For manufacturing and marketing “Dydrogesterone Modified Release Tablets 20 mg”.
Currently, dydrogesterone tablets (10 mg) are available in India in an “immediate release” (IR) format for indications of progesterone deficiency, such as treatment of endometriosis, dysmenorrhea and secondary amenorrhea, irregular cycles, and dysfunctional uterine bleeding.
It is also used in the treatment of threatened abortion and habitual abortion in addition to hormone replacement therapy.
How will the trial be done?
The protocol submitted by the firm, seen by News18, aims to enroll around 230 subjects (115 in each branch) in this study.
“This is a prospective, randomized, single-blind, single-dummy, non-inferiority, two-arm, multicenter study,” said the trial protocol. “Subjects will be randomized (1:1) to receive dydrogesterone modified-release tablets 20 mg OD or dydrogesterone 10 mg IR.”
The duration of treatment – under study – will be three months for each subject. The study will enroll women aged 18 to 45 who have been diagnosed with endometriosis and chronic pelvic pain.
“Subjects will be provided with patient diaries where they will note details about their daily intake of study medication, any concomitant medications including analgesics, and any treatment-emergent adverse events experienced.”
The company has proposed to manufacture the modified formulation at Abbott India Limited’s loan-licensed manufacturing site in Puducherry.
In the trial protocol, the secondary objective behind the study was to assess the quality of life in subjects with endometriosis treated with dydrogesterone ‘modified’ versus ‘immediate release’ in addition to the additional objective of assessing the reduction in endometriosis size with both drugs Is. ,
