Duphaston in patients with irregular periods, apost-marketing observational study.
- Conditions
- Irregular Menstrual Cycle
- Registration Number
- CTRI/2012/03/002523
- Lead Sponsor
- Abbott India Limited
- Brief Summary
The preferred treatment for irregular menstrual cycle is medical management with progesterone1. Progestins have a major role in the prevention of recurrent episodes of menstrual irregularities. It stops endometrial growth and support and organize estrogen-primed endometrium. When progestin therapy is discontinued, an organized slough to the basalis layer of the endometrium occurs, which allows for a rapid cessation of bleeding. In the treatment of oligomenorrhoea, orderly limited withdrawal bleeding can be accomplished by administration of a progestin in a cyclic manner. In the treatment of dysfunctional menorrhagia and polymenorrhoea, progestins are prescribed for up to 2 weeks (to induce stabilizing pre-decidual stromal changes followed by a withdrawal flow). Thereafter, repeat progestin therapy is offered cyclically to ensure therapeutic effect 2.Duphaston, containing dydrogesterone as an active ingredient, is an orally active retro-progesterone which differs only slightly in molecular structure from natural progesterone3, 4. Dydrogesterone has been widely used worldwide for various gynaecological and obstetric indications. It produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection for estrogen induced increased risk for endometrium hyperplasia and/or carcinogenesis. It is indicated in all cases of endogenous progesterone deficiency and has no estrogenic, no androgenic, no thermogenic, no anabolic and no corticoid activity5.
After oral administration of labelled dydrogesterone on average 63% of the dose is excreted into the urine and within 72 hours excretion is complete. Dydrogesterone is completely metabolized and the main metabolite is 20α-dihydrodydrogesterone (DHD) and is present in the urine predominantly as the glucuronic acid conjugate. A common feature of all metabolites characterized is the retention of the 4, 6diene-3-one configuration of the parent compound and the absence of 17 α-hydroxylation and explains the lack of estrogenic and androgenic effects of dydrogesterone. After oral administration of dydrogesterone, plasma concentrations of DHD are substantially higher as compared to the parent drug. Dydrogesterone is rapidly absorbed. Its mean terminal half lives of dydrogesterone and DHD vary between 5 to 7 and 14 to 17 hours, respectively. Dydrogesterone is not excreted in urine as pregnanediol, like progesterone. Analysis of endogenous progesterone production based on pregnanediol excretion therefore remains possible5.
The current study is designed as a non-interventional, observational study. Patients diagnosed with irregular menstrual cycles will be prescribed Duphaston as per the physician’s clinical practice in accordance of the local marketing authorization with regards to dose, population and indication. The patients will be included in the study subject to their consent.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1000
• Women aged 18 years or older • Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert • Patients willing to sign written authorization to provide data for the study.
•Patients having known hypersensitivity to the active ingredient or excipients •Patients having known or suspected progesterone-dependent neoplasms •Patients having vaginal bleeding of unknown etiology •Patients taking oral contraceptives •Pregnant and lactating patients •Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression) •Patients not willing to sign written authorization for informed consent form.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To determine percentage of patients reporting a regular cycle (defined as cycle duration between 21 to 35 days, inclusive) at the end of treatment period. Three Months
- Secondary Outcome Measures
Name Time Method •To describe evolution of amount of menstrual bleeding from baseline to end of treatment, by assessing average number of pads changed per day at baseline and at the end of treatment. Three Months
Trial Locations
- Locations (40)
Dr. Angha pairaiturkar
🇮🇳Pune, MAHARASHTRA, India
Bansal Hospital
🇮🇳Jaipur, RAJASTHAN, India
Bhatia Clinic,
🇮🇳Hyderabad, ANDHRA PRADESH, India
Devona Speciality Clinic
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Amita Gupta
🇮🇳Delhi, DELHI, India
Dr Rasik Sethiya
🇮🇳Pune, MAHARASHTRA, India
Dr Uma Jaiswal
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr. Indumathi Gokul
🇮🇳Bangalore, KARNATAKA, India
Dr. Kusuma Vijay Kumar
🇮🇳Bangalore, KARNATAKA, India
Dr. Mangala Devi
🇮🇳Bangalore, KARNATAKA, India
Scroll for more (30 remaining)Dr. Angha pairaiturkar🇮🇳Pune, MAHARASHTRA, IndiaDr Angha pairaiturkarPrincipal investigator9822330133dranaghapai@gmail.com