| CTRI Number |
CTRI/2023/12/060847 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
The Comparison of Contraceptive pills containing Estetrol/Drospirenone versus Ethinyl Estradiol/Drospirenone in effects on Blood sugar in PCOS women |
|
Scientific Title of Study
|
Exploring the Impact of Combined Oral Contraceptives: Estetrol/Drospirenone vs. Ethinyl Estradiol/Drospirenone on Glucose Tolerance in Polycystic Ovarian Syndrome- An Open-label Crossover Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Phattarika Bunyapipat |
| Designation |
Postgraduate fellowships of reproductive medicine |
| Affiliation |
Prince of Songkhla University |
| Address |
Department of Obstetrics and Gynecology, Faculty of Medicine,
Prince of Songkla University
90110
Other |
| Phone |
66858842988 |
| Fax |
|
| Email |
toeibunyapipat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satit Klangsin |
| Designation |
Assistant Professor |
| Affiliation |
Prince of Songkhla University |
| Address |
Department of Obstetrics and Gynecology, Faculty of Medicine,
Prince of Songkla University
90110
Other |
| Phone |
6674451205 |
| Fax |
|
| Email |
bukungmaru@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Faculty of Medicine Research Scholarship, Prince of Songkhla university |
| Address |
Prince of Songkla University,
15 Kanchanavanit Road, Hat Yai,
Songkhla, 90110 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Thailand |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Phattarika Bunyapipat |
Songklanagarind Hospital |
Gynecology clinic, Songklanagarind Hospital
|
66858842988
toeibunyapipat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee Faculty of Medicine,Prince of Somgkla University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Estetrol/Drospirenone
(NEXTSTELLIS) |
A novel form of combined oral contraception contains 15 mg of estetrol (E4) and 3 mg of drospirenone (DRSP) for 3 months then do not receive any contraceptive pills for 2 months.Subsequently,participants will receive contraceptive pills contains 0.03 mg of ethinyl estradiol and 3 mg of DRSP for 3 months.Total duration is 8 months |
| Comparator Agent |
Ethinyl Estradiol/Drospirenone
(YASMIN) |
Participants will receive contraceptive pills containing 0.03 mg of EE/ 3 mg of DRSP for 3 months, then washout period for 2 months. Subsequently, participants will receive contraceptive pills containing 15 mg of E4/ 3 mg of DRSP for 3 months. Total duration is 8 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
A diagnosis of PCOS according to the modified 2003 Rotterdam diagnostic criteria |
|
| ExclusionCriteria |
| Details |
-Patients with contraindications to the use of COCs, according to MEC categories 3 and 4.
-Smoker
-Pregnancy
-History of hysterectomy or bilateral salpingo-oophorectomy
-Previous chemotherapy or radiation therapy
-Recent use of hormonal drugs within the past 2 months
-Use of medications that reduce the effectiveness of oral contraceptives (such as Rifampicin, Rifabutin, Barbiturates, Carbamazepine, Lamotrigine, Oxcarbazepine, Phenytoin, Primidone, and Topiramate)
-Abnormalities of the pituitary gland (including hyperprolactinemia and adenoma)
-Other ovarian disorders such as premature ovarian failure
-Diabetes
-Abnormal thyroid function
-Patients who have undergone gastric bypass surgery for obesity
-Patients receiving insulin sensitizer drugs such as metformin
-Patients receiving treatment for dyslipidemia
-Patients have the intention to reduce weight
-Patients receiving treatment with GLP-1 receptor agonist
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -To compare the effect between combined oral contraceptives (COCs) containing Estetrol (E4) 15 mg/ drospirenone (DRSP) 3 mg and ethinyl estradiol (EE) 30 mcg/DRSP 3 mg on glucose tolerance(2 hour 75 gm OGTT) in patients with polycystic ovarian syndrome (PCOS). |
At baseline
3 months after exposures
2 months after washout peroid
3 months after cross-over exposures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the effects of different COCs on insulin levels in patients with PCOS.
|
At baseline
3 months after exposures
2 months after washout peroid
3 months after cross-over exposures
|
-To compare the effects of different COCs on menstrual patterns according to FIGO 2018(30) in patients with PCOS.
|
At baseline and every months until 8 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [krantarat@yahoo.com ].
- For how long will this data be available start date provided 01-02-2025 and end date provided 01-02-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Polycystic ovarian syndrome (PCOS), the main endocrine disorder, has an estimated prevalence of 6–10 percent among reproductive-aged women. It is associated with irregular menstruation, infertility, hirsutism, and metabolic syndrome, especially elevated insulin resistance (IR). IR resulted in impaired glucose tolerance (IGT) among 30–40% of PCOS. Treatment of PCOS involves lifestyle modification and medication, especially combined oral contraceptives (COCs), particularly COCs containing drospirenone (DRSP), which inhibits mineralocorticoid effects and demonstrates anti-androgenic activity. COCs containing EE and DRSP did not affect fasting blood sugar (FBS), fasting insulin, HOMA-IR, oral glucose tolerance test (OGTT), or insulin under the curve (IR-AUC) at 3 months compared to baseline. In menopausal women, E4 did not result in any significant change in fasting glucose levels. However, it did exhibit positive effects on insulin resistance, hemoglobin A1c, and glucose tolerance. A novel form of COCs contains 15 mg of E4 and 3 mg of DRSP, which does not affect FBS, or insulin levels in non-PCOS women. Based on treatment in PCOS, there is a lack of studies on the impact of COCs containing E4/DRSP on carbohydrate metabolism. Hence, the objective of this study is to compare COCs containing E4/DRSP versus EE/DRSP on glucose tolerance in PCOS women.
|