Study of the effects of telomerase reactivation with Danazol on ovarian function. A Pilot Study.

Phase 1

• Conditions: low ovarian reserve; MedDRA version: 20.0Level: LLTClassification code 10036602Term: Premature ovarian failureSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-004400-19-ES
• Lead Sponsor: IVIRMA MADRID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

-Provide signed and dated informed consent form.
-Willing to comply with all study procedures and be available for the duration of the study. This include the decision to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol.
-female, aged 30 to 45 years old.
-In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30Kg/m2.
-Women with normal (AMH value must be equal or higher than 2ng/ml) or compromised ovarian reserve (defined as AMH <2ng/ml).
-Not having had any steroid hormones for one month.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnancy or lactation.
-Taking other sexual hormones.
-Women with diseases in heart, liver or kidney or tumors which depend on male sexual hormones or hormone-dependent tumour.
-Women taking anticonvulsants, medicaments for diabetes, anticoagulants and anti-hypertension: Ciclosporin and tacrolimus and other steroids and statins.
-Women suffering irregular genital bleeding or with thrombus or thromboembolic diseases.
-Known allergic reactions to components of the study product (cornstarch and lactose).
-Having received ovulation induction drugs within one month before the inclusion in the study.
-Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.
-Simultaneous participation in another clinical trial or previous participation in this study.
-Participation in another clinical study 2 months before inclusion in the present study that could affect its objectives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified