Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age17-45
SponsorPeking University People's Hospital

About this trial

To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;

No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound

Have a desire for remaining reproductive function or uterus

Good compliance with adjunctive treatment and follow-up

Disqualifiers

Hypersensitivity or contradiction for using MPA or atorvastatin

Pregnancy or potential pregnancy

Confirmed diagnosis of any cancer in reproductive system

Already diagnosed with hyperlipidemia and using lipid-lowering drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medroxyprogesterone acetate + Atorvastatin

    Drug

    MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pathological cumulative complete response rate;

3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,

Time frame
assessed up to 4 months

Secondary outcomes

1

Pathological cumulative complete response rate;

From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,

Time frame
assessed up to 8 months
2

The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue

The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion

Time frame
assessed up to 4 months
3

Overall complete response rate

Pathological response duration

Time frame
up to 2 years
4

Pathological response rate classified by different blood lipid level

Pathological response rate classified by different blood lipid level

Time frame
up to 2 years;

Other outcomes

Sponsors and contacts

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