Female patients PCOS with associated symptoms of mild to moderate acne and hirsutism

Phase 3

Completed

• Conditions: Health Condition 1: null- Female Patients PCOS with associated symptoms of mild to moderate acne and hirsutism

• Registration Number: CTRI/2018/03/012481
• Lead Sponsor: Curatio Health Care I Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Female patients between age 18 to 45 years of age

2.Presence of PCOS with associated symptoms of mild to moderate acne and hirsutism

3.Patients with BMI >28 or Waist Hip Ratio >0.9

4.Patients with 5-50 Non-inflammatory facial lesions, except in the nose region (comedo closed and open comedo -degree 1) and/or 10 to 50 inflammatory facial lesions, except in the nose region (papule and pustule -degree 2)

5.Patients with Ferriman-Gallwey hirsutism score 7 to 20, with Mild to moderate Acne

6.Euthyroid Status

7.Patient must not be pregnant, nursing or intend to become pregnant during the study

8.Patient must agree to practice a medically acceptable form of birth control.

9.Ability to understand and consent to participate in this clinical study, expressed by signing the consent form

10.Patient willing to participate by providing written informed consent

Exclusion Criteria

1.Any finding of clinical observation (clinical assessment / physical) that is interpreted by the investigator as a risk to safety or which may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;

2.Any laboratory examination found that the investigator considers as safety risk or that may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;

3.Patients already taking or requiring Hormonal Treatment during study duration

4.Other condition causing ovulatory disorders or androgen excess as hyperprolactinaemia, hypothyroidism, adrenal hyperplasia and Cushingâ??s syndrome

5.Known hypersensitivity to the drug components used during the study;

6.Patients with Uncontrolled or poorly controlled Diabetes Mellitus (HbA1C >6.5)

7.Patients with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding

8.Patients in the reproductive age who do not agree touse acceptable contraception [intrauterinedevice (IUD), barrier methods and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy) or sexual abstinence or who have not yet initiated sexual activity;

9.Presence of dermatoses related to diabetes mellitus (plantar ulcer, necrobiosis lipoid, annular granuloma, dermatophytosis, deep mycoses, bacterial infections, opportunistic infections)

10.Presence of dermatological diseases in the test area (face): vitiligo, psoriasis, atopic dermatitis

11.Participant with cyst or lump in the face region; other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified